Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-26 @ 3:10 AM
Study NCT ID:
NCT02054702
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2014-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591922', 'term': 'brexpiprazole'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 'Adverse events were reported from the signing of informed consent throughout the 6-week treatment period until the follow-up visit 30 days (+2) after the last dose of study medication.', 'description': 'Participants with adverse events were counted only once towards the total.', 'eventGroups': [{'id': 'EG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.', 'otherNumAtRisk': 64, 'otherNumAffected': 36, 'seriousNumAtRisk': 64, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.', 'otherNumAtRisk': 33, 'otherNumAffected': 21, 'seriousNumAtRisk': 33, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Acute hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Presynscope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-19.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.045', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '-0.024', 'spread': '0.081', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4244', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.7623', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery of Early Phase Battery Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.113', 'spread': '0.091', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8759', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.2176', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8420', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.3781', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery Scores of Detection Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.024', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '-0.029', 'spread': '0.026', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1807', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.2802', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery Scores of Identification Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '-0.011', 'spread': '0.016', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8622', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.4848', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.003', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.027', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8588', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '0.9928', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered 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 randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6', 'description': "The efficacy of trial 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. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. 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 randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.'}, {'type': 'SECONDARY', 'title': 'Response Rate by Study Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '48.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'description': 'The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '10.9'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '10.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject\'s quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '0.0392', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.', 'testedNonInferiority': False}, {'pValue': '0.9716', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'FG001', 'title': 'Aripiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The trial was conducted in 97 participants at 19 trial sites in United States.', 'preAssignmentDetails': 'The trial consisted of a 2- to 14-day screening phase, a 6-week treatment phase, and a 30-day follow-up phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brexpiprazole', 'description': 'Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.'}, {'id': 'BG001', 'title': 'Arpiprazole', 'description': 'Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2015-06-17', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-02-02', 'dispFirstSubmitQcDate': '2015-06-17', 'resultsFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2014-02-02', 'dispFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-28', 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Cognitive Test Battery Composite Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.'}, {'measure': 'Change From Baseline in Cognitive Test Battery of Early Phase Battery Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.'}, {'measure': 'Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.'}, {'measure': 'Change From Baseline in Cognitive Test Battery Scores of Detection Task', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.'}, {'measure': 'Change From Baseline in Cognitive Test Battery Scores of Identification Task', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.'}, {'measure': 'Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task', 'timeFrame': 'Baseline to Week 6', 'description': 'The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.'}, {'measure': 'Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered 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 in Clinical Global Impression-Improvement (CGI-I) Score at Week 6', 'timeFrame': 'Baseline to Week 6', 'description': "The efficacy of trial 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. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. 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': 'Response Rate by Study Week', 'timeFrame': 'Baseline to Week 6', 'description': 'The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).'}, {'measure': 'Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject\'s quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant.'}, {'measure': 'Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Mental Disorders', 'Psychotic Disorders', 'Antipsychotic', 'Cognitive testing'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies\n* Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry\n* Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:\n* Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80\n* Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness\n* Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)\n\nExclusion Criteria:\n\n* Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator\n* Have been hospitalized \\> 21 days for the current acute episode at the time of the baseline visit\n* Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.\n* Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.'}, 'identificationModule': {'nctId': 'NCT02054702', 'briefTitle': 'Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia', 'orgStudyIdInfo': {'id': '331-13-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brexpiprazole', 'description': 'Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally', 'interventionNames': ['Drug: Brexpiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole', 'description': 'Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Brexpiprazole', 'type': 'DRUG', 'description': 'Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally', 'armGroupLabels': ['Brexpiprazole']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Up to 20 mg/day, once daily dose, tablets, orally', 'armGroupLabels': ['Aripiprazole']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Junichi Hashimoto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}