Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT01360632
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2011-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 562-3974', 'title': 'Global Medical Affairs', 'organization': 'Otsuka Pharmaceutical Development and Commercialization, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were captured from randomization to double-blind treatment at Week 8 to Follow-up 30 (+ 2) days after last dose of study medication.', 'description': 'Safety sample comprised of randomized participants in Phase B who received at least one dose of double-blind trial medication. Participants were excluded only if there was evidence that the participant did not take trial medication. If a participant was dispensed trial medication and is lost to follow-up that participant was considered exposed.', 'eventGroups': [{'id': 'EG000', 'title': 'Brexpiprazole (1mg + ADT)', 'description': 'Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.', 'otherNumAtRisk': 226, 'otherNumAffected': 63, 'seriousNumAtRisk': 226, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Brexpiprazole (3mg + ADT)', 'description': 'Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.', 'otherNumAtRisk': 229, 'otherNumAffected': 72, 'seriousNumAtRisk': 229, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo as an adjunctive therapy to an open label ADT.', 'otherNumAtRisk': 220, 'otherNumAffected': 29, 'seriousNumAtRisk': 220, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.65', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-7.98', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-6.45', 'spread': '0.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0925', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '0.2', 'groupDescription': 'The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0327', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '-0.13', 'groupDescription': 'The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'PRIMARY', 'title': 'Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.64', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-8.29', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '6.33', 'spread': '0.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0737', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-2.73', 'ciUpperLimit': '0.13', 'groupDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0079', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '-0.51', 'groupDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-2.19', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-5.34', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-3.91', 'spread': '0.39', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-6.25', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-5.56', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '-4.85', 'spread': '0.41', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-7.08', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-5.52', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-7.55', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-7.73', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-6.04', 'spread': '0.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0096', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '-0.26', 'groupDescription': 'Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.4137', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '0.47', 'groupDescription': 'Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0065', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-2.47', 'ciUpperLimit': '-0.4', 'groupDescription': 'Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate', 'testedNonInferiority': False}, {'pValue': '0.0914', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.14', 'groupDescription': 'Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0139', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-0.28', 'groupDescription': 'Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.2097', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '0.4', 'groupDescription': 'Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0099', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '-0.38', 'groupDescription': 'Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.034', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '-0.1', 'groupDescription': 'Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0177', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.27', 'groupDescription': 'Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0085', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.98', 'ciUpperLimit': '-0.44', 'groupDescription': 'Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8, 9, 10, 11, 12, and 13', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-3.09', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-5.12', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-3.95', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-6.22', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-5.76', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-4.86', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-7.09', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-7.11', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-5.48', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-7.56', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-8.05', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-5.93', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0286', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.74', 'ciUpperLimit': '-0.1', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.3173', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '0.4', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0313', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '-0.11', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate', 'testedNonInferiority': False}, {'pValue': '0.0732', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '0.09', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0206', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '-0.21', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1233', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '0.25', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.61', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '-0.39', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0092', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.63', 'ciLowerLimit': '-2.86', 'ciUpperLimit': '-0.41', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0139', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.63', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '-0.33', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.12', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '-0.81', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8, 9, 10, 11, 12, and 13', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 11', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.23', 'pValueComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5792', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.23', 'pValueComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.12', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0474', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 11 and Week 14', 'description': 'The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 11', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.78', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.22', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2627', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.15', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0191', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.08', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 11 and Week 14', 'description': 'The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Work/school: Week 11', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Work/school: Week 14', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Social life: Week 11', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Social life: Week 14', 'categories': [{'measurements': [{'value': '-1.39', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Family life: Week 11', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Family life: Week 14', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0377', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.03', 'groupDescription': 'For Item: Work/School: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0741', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.04', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'estimateComment': '-0.43', 'groupDescription': 'For Item: Work/School: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0966', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.81', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'For Item: Work/School: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4774', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.31', 'groupDescription': 'For Item: Work/School: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0263', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.05', 'pValueComment': 'MMRM method was used with trial site; 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treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Family life: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0093', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '-0.14', 'groupDescription': 'Family life: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2182', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.14', 'groupDescription': 'Family life: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0256', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.06', 'pValueComment': 'MMRM method was used with trial site; 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treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Social life: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.24', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Family life: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0186', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.09', 'groupDescription': 'Family life: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0824', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.04', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Family life: Week 11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.16', 'pValueComment': 'MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.', 'groupDescription': 'Family life: Week 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 11 and Week 14', 'description': "The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.03', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0436', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '-0.06', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.03', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.08', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0266', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '-0.02', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.07', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.3053', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.06', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0541', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0912', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.02', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1553', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.04', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1855', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.05', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.2015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.06', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0852', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.02', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8, 9, 10, 11, 12,13 and 14', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.03', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0817', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.01', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1406', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.02', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.04', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0287', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '-0.02', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '-0.05', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.2503', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '-0.06', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0539', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0398', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.01', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1168', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.03', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.01', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.02', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0213', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.03', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-3.58', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-2.68', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-2.31', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-4.97', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-4.00', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-5.83', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-4.15', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-3.74', 'spread': '0.57', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-6.33', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-5.77', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '-4.43', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-6.96', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-6.62', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-5.66', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-7.02', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-6.94', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '-5.42', 'spread': '0.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0228', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '-0.18', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.5081', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '0.73', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0064', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.86', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-0.53', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1898', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '0.44', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0074', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.09', 'ciLowerLimit': '-3.62', 'ciUpperLimit': '-0.56', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.5935', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '1.11', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0211', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.52', 'ciUpperLimit': '-0.29', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-2.96', 'ciUpperLimit': '0.27', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1366', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1366', 'ciLowerLimit': '-3.02', 'ciUpperLimit': '0.41', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.2709', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '0.75', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0812', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '0.2', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.1001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-3.33', 'ciUpperLimit': '0.29', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '-3.27', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-2.65', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-2.15', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-4.13', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-5.77', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-3.46', 'spread': '0.59', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-6.33', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-6.05', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '-4.18', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-6.88', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-6.97', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '-5.25', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-6.97', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-5.07', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0496', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-2.24', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.387', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '0.63', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0125', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.75', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '-0.38', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0898', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-2.57', 'ciUpperLimit': '0.19', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.31', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '-0.74', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.301', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.74', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0118', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.15', 'ciLowerLimit': '-3.82', 'ciUpperLimit': '-0.48', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0287', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.87', 'ciLowerLimit': '-3.54', 'ciUpperLimit': '-0.19', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0686', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.63', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '0.12', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '0.04', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0448', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '-0.04', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}, {'pValue': '0.0251', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.13', 'ciLowerLimit': '-3.98', 'ciUpperLimit': '-0.27', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.47', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-6.14', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1732', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '0.29', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0066', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-2.31', 'ciUpperLimit': '-0.37', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the "best" rating and the highest score (2 or 4) was the "worst" rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.36', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-6.26', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1226', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '0.21', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.69', 'ciLowerLimit': '-2.69', 'ciUpperLimit': '-0.68', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the "best" rating and the highest score (2 or 4) was the "worst" rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.43', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-3.33', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8164', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.73', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1939', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '0.28', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the "best" rating and 4 is the "worst" rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.35', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-3.96', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-3.07', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '0.57', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0443', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-1.75', 'ciUpperLimit': '-0.02', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the "best" rating and 4 is the "worst" rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '3.36', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '0.67', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '3.08', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '3.34', 'spread': '0.85', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '2.91', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '3.17', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '3.02', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '2.72', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '2.97', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '2.69', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.85', 'spread': '1.01', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0248', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '-0.02', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.1334', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.03', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.11', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.11', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center', 'testedNonInferiority': False}, {'pValue': '0.0254', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.02', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.08', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0152', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '-0.04', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.08', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.05', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0755', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.02', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0527', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 8 to Week 14', 'description': "The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.\n\nResponse choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '3.39', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '3.54', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '0.84', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '2.93', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '1', 'groupId': 'OG001'}, {'value': '3.01', 'spread': '0.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '-0.01', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.1583', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.04', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.11', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0235', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.03', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.10', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0111', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.05', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.09', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0237', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '-0.03', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}, {'pValue': '0.0171', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.04', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': "The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0.45', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '6.19', 'groupId': 'OG001'}, {'value': '5.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}, {'value': '8.72', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}, {'value': '15.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5279', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.51', 'ciUpperLimit': '3.68', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0141', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.94', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0484', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '0.99', 'ciUpperLimit': '3.72', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.5813', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.60', 'ciUpperLimit': '2.50', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1236', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.54', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.4998', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.10', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0365', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.03', 'ciUpperLimit': '2.61', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0822', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.95', 'ciUpperLimit': '2.43', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.4049', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.78', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2951', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.80', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0248', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.06', 'ciUpperLimit': '2.20', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0326', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.03', 'ciUpperLimit': '2.21', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'MADRS response was defined as \\>=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000'}, {'value': '0.48', 'groupId': 'OG001'}, {'value': '3.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '7.58', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '4.93', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '8.37', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7993', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.30', 'ciUpperLimit': '2.55', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0118', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.93', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2825', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.71', 'ciUpperLimit': '3.16', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.6375', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.50', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0923', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.82', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3812', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.30', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0464', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.65', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0490', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.64', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2124', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.06', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1078', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.14', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0094', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.50', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0162', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.50', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'MADRS response was defined as \\>=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000'}, {'value': '0.45', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2.65', 'groupId': 'OG001'}, {'value': '4.13', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '8.44', 'groupId': 'OG000'}, {'value': '6.19', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '8.85', 'groupId': 'OG001'}, {'value': '5.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}, {'value': '9.17', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '13.7', 'groupId': 'OG001'}, {'value': '11.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9498', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of remission rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.37', 'ciUpperLimit': '2.90', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0141', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.94', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.8609', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.40', 'ciUpperLimit': '2.17', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2846', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.54', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2480', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.99', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.7513', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.37', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0554', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '0.99', 'ciUpperLimit': '3.35', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2409', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.87', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.5538', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.02', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1743', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.41', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2843', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.07', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.4640', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.92', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'MADRS remission was defined as a \\< or equal to 10 and \\> or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000'}, {'value': '0.48', 'groupId': 'OG001'}, {'value': '3.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '2.37', 'groupId': 'OG000'}, {'value': '2.82', 'groupId': 'OG001'}, {'value': '3.94', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '8.06', 'groupId': 'OG000'}, {'value': '6.57', 'groupId': 'OG001'}, {'value': '5.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '9.39', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}, {'value': '8.37', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '14.1', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3867', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.97', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0118', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.93', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3200', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.66', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3266', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.62', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3027', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.70', 'ciUpperLimit': '3.10', 'groupDescription': 'Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.6960', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.52', 'groupDescription': 'Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1368', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.86', 'ciUpperLimit': '3.07', 'pValueComment': 'CMH general association test controlling for trial site', 'groupDescription': 'Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2387', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.89', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.4498', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.28', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.82', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1499', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.41', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3012', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.78', 'ciUpperLimit': '2.18', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'MADRS remission was defined as a \\< or equal to 10 and \\> or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '9.46', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '6.54', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '38.1', 'groupId': 'OG001'}, {'value': '29.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43.4', 'groupId': 'OG001'}, {'value': '28.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}, {'value': '36.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2873', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.65', 'groupDescription': 'Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2677', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.36', 'groupDescription': 'Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '1.21', 'ciUpperLimit': '2.68', 'groupDescription': 'Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0066', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '1.15', 'ciUpperLimit': '2.50', 'groupDescription': 'Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0665', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.83', 'groupDescription': 'Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0250', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.91', 'groupDescription': 'Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.2224', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.54', 'groupDescription': 'Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0369', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.68', 'groupDescription': 'Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0179', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.75', 'groupDescription': 'Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.89', 'groupDescription': 'Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3249', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.41', 'groupDescription': 'Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0122', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.66', 'groupDescription': 'Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG001', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'OG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo daily as an adjunctive therapy to an open label ADT.'}], 'classes': [{'title': 'Week 9', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}, {'value': '9.52', 'groupId': 'OG001'}, {'value': '5.53', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '19.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '27.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '27.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '48.4', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5836', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.60', 'ciUpperLimit': '2.49', 'groupDescription': 'Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.3792', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.37', 'groupDescription': 'Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0101', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.74', 'groupDescription': 'Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Ratio of response rate', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0065', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '1.17', 'ciUpperLimit': '2.63', 'groupDescription': 'Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0526', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.99', 'groupDescription': 'Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0156', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.11', 'groupDescription': 'Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1689', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.63', 'groupDescription': 'Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0231', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.80', 'groupDescription': 'Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0175', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.84', 'groupDescription': 'Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '1.22', 'ciUpperLimit': '2.07', 'groupDescription': 'Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.1396', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.55', 'groupDescription': 'Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}, {'pValue': '0.0016', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.86', 'groupDescription': 'Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH general association test controlling for trial site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks, 8, 9, 10, 11, 12, 13, and 14', 'description': 'A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single-blind Placebo + ADT', 'description': 'In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.'}, {'id': 'FG001', 'title': 'Brexpiprazole (1mg) + ADT', 'description': 'Participants were administered brexpiprazole of \\[1mg (milligram)\\] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).'}, {'id': 'FG002', 'title': 'Brexpiprazole (3mg) + ADT', 'description': 'Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'FG003', 'title': 'Double-blind Placebo + ADT', 'description': 'In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.'}, {'id': 'FG004', 'title': 'Phase A+ Placebo + ADT', 'description': 'Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+'}], 'periods': [{'title': 'Phase A (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A total of 1539 participants were enrolled, 7 discontinued before taking any sponsor-provided ADT', 'groupId': 'FG000', 'numSubjects': '1532'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1277'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Phase B (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG001', 'numSubjects': '226'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG002', 'numSubjects': '230'}, {'comment': 'These participants were from the randomized sample.', 'groupId': 'FG003', 'numSubjects': '221'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '210'}, {'groupId': 'FG003', 'numSubjects': '208'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Phase A+', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '600'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '575'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted in 1539 participants at 92 trial sites in 7 countries. United States, Germany, Ukraine, Russia, Hungary, Canada, and Romania.', 'preAssignmentDetails': 'The study consisted of a 7 to 28-day Screening period, an 8-Week single-blind placebo + ADT prospective Phase-A, a 6-Week double-blind randomization Phase-B or single-blind Phase A+ and a Follow-up of 30 (+2) days after the last dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '677', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Brexpiprazole (1mg + ADT)', 'description': 'Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'BG001', 'title': 'Brexpiprazole (3mg + ADT)', 'description': 'Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.'}, {'id': 'BG002', 'title': 'Placebo + ADT', 'description': 'Participants were administered placebo as an adjunctive therapy to an open label ADT.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '46.6', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '45.6', 'spread': '11.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '460', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1539}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2014-10-14', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2011-05-24', 'dispFirstSubmitQcDate': '2014-10-14', 'resultsFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2011-05-24', 'dispFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-30', 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set', 'timeFrame': 'Baseline and Week 14', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Baseline and Week 14', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set', 'timeFrame': 'Week 8, 9, 10, 11, 12, and 13', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Week 8, 9, 10, 11, 12, and 13', 'description': 'The MADRS was utilized as the primary efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set', 'timeFrame': 'Week 11 and Week 14', 'description': 'The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Week 11 and Week 14', 'description': 'The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.'}, {'measure': 'Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set', 'timeFrame': 'Week 11 and Week 14', 'description': "The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable."}, {'measure': 'Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol', 'timeFrame': 'Week 11 and Week 14', 'description': "The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable."}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set', 'timeFrame': 'Weeks 8, 9, 10, 11, 12,13 and 14', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the "best" rating and the highest score (2 or 4) was the "worst" rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the "best" rating and the highest score (2 or 4) was the "worst" rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the "best" rating and 4 is the "worst" rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.'}, {'measure': 'Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Baseline and Week 14', 'description': 'The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the "best" rating and 4 is the "worst" rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms.'}, {'measure': 'Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set', 'timeFrame': 'Week 8 to Week 14', 'description': "The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.\n\nResponse choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."}, {'measure': 'Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': "The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."}, {'measure': 'Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'MADRS response was defined as \\>=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13, and 14', 'description': 'MADRS response was defined as \\>=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'MADRS remission was defined as a \\< or equal to 10 and \\> or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'MADRS remission was defined as a \\< or equal to 10 and \\> or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant\'s level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.'}, {'measure': 'Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set', 'timeFrame': 'Weeks 8, 9, 10, 11, 12, 13 and 14', 'description': 'A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).'}, {'measure': 'Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol', 'timeFrame': 'Weeks, 8, 9, 10, 11, 12, 13, and 14', 'description': 'A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OPC-34712', 'brexpiprazole', 'Major Depressive Disorder', 'Adjunctive Treatment'], 'conditions': ['Depressive Disorder', 'Depression', 'Depressive Disorder, Major', 'Mood Disorders', 'Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '41055581', 'type': 'DERIVED', 'citation': 'Kapadia S, Zhang Z, Ardic F, Patel M, Thase ME, Papakostas GI. Adjunctive brexpiprazole in patients with major depressive disorder who show minimal or partial response to antidepressant treatment: post hoc analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2025 Oct 1;28(10):pyaf074. doi: 10.1093/ijnp/pyaf074.'}, {'pmid': '40852147', 'type': 'DERIVED', 'citation': 'Ardic F, Zhang Z, Hogan M. Effects of adjunctive brexpiprazole in patients with major depressive disorder and sleep disturbance: a post hoc analysis of three randomized trials. Front Psychiatry. 2025 Aug 7;16:1618176. doi: 10.3389/fpsyt.2025.1618176. eCollection 2025.'}, {'pmid': '40607746', 'type': 'DERIVED', 'citation': 'Kapadia S, Zhang Z, Csoboth C, Patel M, Thase ME, Papakostas GI. Adjunctive brexpiprazole in patients with unresolved symptoms of depression on antidepressant treatment who are early in the disease course: post hoc analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2025 Aug 1;28(8):pyaf050. doi: 10.1093/ijnp/pyaf050.'}, {'pmid': '38421922', 'type': 'DERIVED', 'citation': 'McIntyre RS, Bubolic S, Zhang Z, MacKenzie EM, Therrien F, Miguelez M, Boucher M. Effects of Adjunctive Brexpiprazole on Individual Depressive Symptoms and Functioning in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of Three Placebo-Controlled Studies. J Clin Psychopharmacol. 2024 Mar-Apr 01;44(2):133-140. doi: 10.1097/JCP.0000000000001825.'}, {'pmid': '37656180', 'type': 'DERIVED', 'citation': 'Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.'}, {'pmid': '37099968', 'type': 'DERIVED', 'citation': 'McIntyre RS, Therrien F, Ismail Z, Meehan SR, Miguelez M, Larsen KG, Chen D, MacKenzie EM, Thase ME. Effects of adjunctive brexpiprazole on patient life engagement in major depressive disorder: Post hoc analysis of Inventory of Depressive Symptomatology Self-Report data. J Psychiatr Res. 2023 Jun;162:71-78. doi: 10.1016/j.jpsychires.2023.04.012. Epub 2023 Apr 12.'}, {'pmid': '31577867', 'type': 'DERIVED', 'citation': 'Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.'}, {'pmid': '30508090', 'type': 'DERIVED', 'citation': 'Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.'}, {'pmid': '27208498', 'type': 'DERIVED', 'citation': 'McIntyre RS, Weiller E, Zhang P, Weiss C. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials. J Affect Disord. 2016 Sep 1;201:116-23. doi: 10.1016/j.jad.2016.05.013. Epub 2016 May 12.'}, {'pmid': '26301771', 'type': 'DERIVED', 'citation': 'Thase ME, Youakim JM, Skuban A, Hobart M, Zhang P, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. Adjunctive brexpiprazole 1 and 3 mg for patients with major depressive disorder following inadequate response to antidepressants: a phase 3, randomized, double-blind study. J Clin Psychiatry. 2015 Sep;76(9):1232-40. doi: 10.4088/JCP.14m09689.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria\n* The current depressive episode must be equal to or greater than 8 weeks in duration\n* Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments\n\nExclusion Criteria:\n\n* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug\n* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration\n* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder\n* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder'}, 'identificationModule': {'nctId': 'NCT01360632', 'acronym': 'Polaris', 'briefTitle': 'Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)', 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