Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-23 @ 12:23 PM
Study NCT ID:
NCT03739203
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2018-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)', 'description': 'Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 54, 'seriousNumAtRisk': 250, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cariprazine 1.5 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 70, 'seriousNumAtRisk': 250, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cariprazine 3 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 85, 'seriousNumAtRisk': 251, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'AKATHISIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 40, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ANIMAL BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'OG001', 'title': 'Cariprazine 1.5 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'OG002', 'title': 'Cariprazine 3 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.4', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.10', 'ciUpperLimit': '1.37', 'pValueComment': 'p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.88', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\\& BL by-visit interaction.'}, {'pValue': '0.1245', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '0.38', 'pValueComment': 'p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.89', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\\& BL by-visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': "The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed are the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'OG001', 'title': 'Cariprazine 1.5 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'OG002', 'title': 'Cariprazine 3 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.15', 'pValueComment': 'p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\\& BL by-visit interaction.'}, {'pValue': '0.0573', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.01', 'pValueComment': 'p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\\& BL by-visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': "The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed are the number of participants with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \\[same antidepressant and dose of ADT they were on at the Baseline\\] during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'FG001', 'title': 'Cariprazine 1.5 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'FG002', 'title': 'Cariprazine 3 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.'}], 'periods': [{'title': 'Double-blind Treatment Period (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '251'}]}, {'type': 'Modified Intent-to Treat (mITT) Population', 'comment': 'mITT population included all randomized participants who had ≥1 postbaseline assessment of the Montgomery-Asberg Depression Rating Scale (MADRS) total score.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Safety Follow-Up Period (4 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'As per protocol-defined criteria, some of the participants discontinued from the Double-blind Period but entered the Safety Follow-up Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '242'}, {'groupId': 'FG002', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'A total of 752 participants were enrolled, of which 751 took ≥1 dose of double-blind investigational product and were included in the Safety Population. One participant was randomized but did not receive treatment and was excluded from the study analyses. At the end of treatment in the Double-blind Period, participants continued on their background antidepressant therapy (ADT) and entered the Safety Follow-up Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'BG001', 'title': 'Cariprazine 1.5 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'BG002', 'title': 'Cariprazine 3 mg/Day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '46.2', 'spread': '12.12', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '12.95', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '12.45', 'groupId': 'BG002'}, {'value': '45.7', 'spread': '12.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '573', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '649', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '654', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '750', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '32.99', 'spread': '4.789', 'groupId': 'BG000'}, {'value': '32.00', 'spread': '4.246', 'groupId': 'BG001'}, {'value': '32.25', 'spread': '4.688', 'groupId': 'BG002'}, {'value': '32.41', 'spread': '4.593', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.'}, {'title': 'Clinical Global Impression-Severity (CGI-S) Scale Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '750', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '0.599', 'groupId': 'BG000'}, {'value': '4.61', 'spread': '0.586', 'groupId': 'BG001'}, {'value': '4.65', 'spread': '0.654', 'groupId': 'BG002'}, {'value': '4.64', 'spread': '0.614', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.'}], 'populationDescription': 'Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-31', 'size': 943982, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-26T16:11', 'hasProtocol': True}, {'date': '2021-07-28', 'size': 797755, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-26T15:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 752}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2018-11-09', 'resultsFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-26', 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score', 'timeFrame': 'Baseline and Week 6', 'description': "The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score', 'timeFrame': 'Baseline and Week 6', 'description': "The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDD'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '37585254', 'type': 'DERIVED', 'citation': 'Riesenberg R, Yeung PP, Rekeda L, Sachs GS, Kerolous M, Fava M. Cariprazine for the Adjunctive Treatment of Major Depressive Disorder in Patients With Inadequate Response to Antidepressant Therapy: Results of a Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2023 Aug 16;84(5):22m14643. doi: 10.4088/JCP.22m14643.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'VRAYLAR® (cariprazine) capsules prescribing information.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent has been obtained.\n* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information \\[US sites\\] and written Data Protection consent \\[EU sites\\]).\n* Participant must be an outpatient at the time of Visit 1 (Screening).\n* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5 (SCID-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.\n* Diagnosis of MDD confirmed through a formal adjudication process.\n* Participant demonstrates ability to follow study instructions and likely to complete all required visits.\n* Participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (ATRQ), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.\n* Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and Participants must agree to continue taking the same ADT dosing regimen through completion of Visit 6/early termination (ET). Participants who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).\n* Male and female Participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.\n* Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.\n\nExclusion Criteria:\n\n* Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.\n* Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.'}, 'identificationModule': {'nctId': 'NCT03739203', 'briefTitle': 'The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone', 'orgStudyIdInfo': {'id': '3111-302-001'}, 'secondaryIdInfos': [{'id': '2018-003164-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + ADT', 'description': 'Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \\[same antidepressant and dose of ADT they were on at the Baseline\\] during the Double-blind Treatment Period, up to Week 6.', 'interventionNames': ['Drug: Placebo', 'Drug: Antidepressant Therapy (ADT)']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine 1.5 mg/day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.', 'interventionNames': ['Drug: Cariprazine', 'Drug: Antidepressant Therapy (ADT)']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine 3 mg/day + ADT', 'description': 'Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.', 'interventionNames': ['Drug: Cariprazine', 'Drug: Antidepressant Therapy (ADT)']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'otherNames': ['VRAYLAR®'], 'description': 'Cariprazine supplied in capsules', 'armGroupLabels': ['Cariprazine 1.5 mg/day + ADT', 'Cariprazine 3 mg/day + ADT']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo supplied in capsules', 'armGroupLabels': ['Placebo + ADT']}, {'name': 'Antidepressant Therapy (ADT)', 'type': 'DRUG', 'description': 'ADT as prescribed by the physician per standard of care in clinical practice.', 'armGroupLabels': ['Cariprazine 1.5 mg/day + ADT', 'Cariprazine 3 mg/day + ADT', 'Placebo + ADT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Harmonex /ID# 236936', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group /ID# 236349', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92804-3738', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'California Pharmaceutical Research Institute /ID# 236731', 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}