Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT00665366
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2008-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
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We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole', 'otherNumAtRisk': 180, 'otherNumAffected': 45, 'seriousNumAtRisk': 180, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 189, 'otherNumAffected': 29, 'seriousNumAtRisk': 189, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intentional drug misuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.54', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-13.57', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '0.07', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=183, 174)', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=186, 176)', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=186, 176)', 'categories': [{'measurements': [{'value': '-1.55', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=186, 176)', 'categories': [{'measurements': [{'value': '-1.78', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.25', 'estimateComment': 'Week 3', 'statisticalMethod': 'ANOVA/ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.16', 'estimateComment': 'Week 6', 'statisticalMethod': 'ANOVA/ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.00', 'estimateComment': 'Week 9', 'statisticalMethod': 'ANOVA/ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.01', 'estimateComment': 'Week 12', 'statisticalMethod': 'ANOVA/ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=183, 174)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=186, 176)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=186, 176)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=186, 176)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.06', 'estimateComment': 'Week 3', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.843', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.19', 'estimateComment': 'Week 6', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.35', 'estimateComment': 'Week 9', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.109', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.38', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Week 12', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.51', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.567', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.20', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Week 12', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Total score: Week 3 (n=179, 169)', 'categories': [{'measurements': [{'value': '-5.68', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-5.00', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Total score: Week 6 (n=182, 171)', 'categories': [{'measurements': [{'value': '-8.59', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-6.93', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Total score: Week 9 (n=182, 171)', 'categories': [{'measurements': [{'value': '-9.18', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-7.71', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Total score: Week 12 (n=182, 171)', 'categories': [{'measurements': [{'value': '-10.39', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-8.51', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy score: Week 3 (n=179, 169)', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy score: Week 6 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy score: Week 9 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy score: Week 12 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.84', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Occupational function score: Week 3 (n=179, 169)', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Occupational function score: Week 6 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Occupational function score: Week 9 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Occupational function score: Week 12 (n=182, 171)', 'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive function score: Week 3 (n=179, 169)', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive function score: Week 6 (n=182, 171)', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '0.26', 'groupId': 'OG000'}, 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[{'value': '-2.41', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'IP relationships score: Week 12 (n=182, 171)', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-2.31', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Leisure time score: Week 3 (n=179, 169)', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Leisure time score: Week 6 (n=182, 171)', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Leisure time score: Week 9 (n=182, 171)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Leisure time score: Week 12 (n=182, 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'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '4.84', 'estimateComment': 'Total score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.48', 'estimateComment': 'Autonomy score: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.85', 'estimateComment': 'Autonomy score: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.93', 'estimateComment': 'Autonomy score: Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.96', 'estimateComment': 'Autonomy score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.311', 'groupIds': 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Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '1.35', 'estimateComment': 'Cognitive functioning score: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.34', 'estimateComment': 'Cognitive functioning score: Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '1.42', 'estimateComment': 'Cognitive functioning score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.93', 'estimateComment': 'Interpersonal relationships score: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.06', 'estimateComment': 'Interpersonal relationships score: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '1.10', 'estimateComment': 'Interpersonal relationships score: Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '1.09', 'estimateComment': 'Interpersonal relationships score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.52', 'estimateComment': 'Leisure time score: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.54', 'estimateComment': 'Leisure time score: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.35', 'estimateComment': 'Leisure time score: Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.641', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.44', 'estimateComment': 'Leisure time score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.61', 'estimateComment': 'Financial issues score: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.74', 'estimateComment': 'Financial issues score: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.60', 'estimateComment': 'Financial issues score: Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.57', 'estimateComment': 'Financial issues score: Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': 'The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0\\*24)to 96 (4\\*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=183, 174)', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=186, 176)', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '49.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=186, 176)', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '64.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=186, 176)', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '68.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.59', 'estimateComment': 'Week 3', 'statisticalMethod': 'Ration of response', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.540', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.32', 'estimateComment': 'Week 6', 'statisticalMethod': 'Risk ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.38', 'estimateComment': 'Week 9', 'statisticalMethod': 'Risk ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Risk ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=183, 174)', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=186, 176)', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=186, 176)', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=186, 176)', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}, {'value': '69.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.909', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.39', 'estimateComment': 'Week 3', 'statisticalMethod': 'Risk ratio (RR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.30', 'estimateComment': 'Week 6', 'statisticalMethod': 'RR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.36', 'estimateComment': 'Week 9', 'statisticalMethod': 'RR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.211', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.27', 'estimateComment': 'Week 12', 'statisticalMethod': 'RR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 3,6, 9, and 12', 'description': "Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 6 (n=146, 135)', 'categories': [{'measurements': [{'value': '-2.13', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=123, 115)', 'categories': [{'measurements': [{'value': '-3.20', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-2.37', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (LOCF) (n=165, 150)', 'categories': [{'measurements': [{'value': '-2.30', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.29', 'estimateComment': 'Week 6', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.58', 'estimateComment': 'Week 12', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '1.34', 'estimateComment': 'Week 12 (LOCF)', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 6 and 12', 'description': 'Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=178, 168)', 'categories': [{'measurements': [{'value': '2.94', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=151, 140)', 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=127, 119)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (LOCF) (n=181, 173)', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.32', 'estimateComment': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.53', 'estimateComment': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.54', 'estimateComment': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.63', 'estimateComment': 'Week 12 (LOCF)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Week 3 (n=177, 171)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=152,144)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=142, 128)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=133, 123)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (LOCF) (n=183, 174)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.64', 'estimateComment': 'Week 12 LOCF', 'statisticalMethod': 'ANOVA/ANCOVA model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': 'Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'title': 'Weight gain: Week 12 (n=184,174)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Weight loss: Week 12 (n=184,174)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.57', 'ciUpperLimit': '3.71', 'statisticalMethod': 'Risk Ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Weight gain', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and12', 'description': 'Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'OG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.582', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'BMI=Weight in kilograms /(Height in meters\\^2). LOCF=last observation carried forward.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'FG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants randomized', 'groupId': 'FG000', 'numSubjects': '189'}, {'comment': 'Participants randomized', 'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Poor compliance/noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of 493 participants enrolled, 370 were randomized, and 369 received treatment with double-blind study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Valproate or Lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.'}, {'id': 'BG001', 'title': 'Aripiprazole + Valproate or Lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.92', 'spread': '12.99', 'groupId': 'BG000'}, {'value': '44.37', 'spread': '12.13', 'groupId': 'BG001'}, {'value': '44.65', 'spread': '12.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2008-04-18', 'resultsFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2008-04-22', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-01', 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)', 'timeFrame': 'Baseline to Week 12', 'description': "The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward."}, {'measure': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward."}, {'measure': 'Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)', 'timeFrame': 'Baseline to Week 12', 'description': "Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward."}, {'measure': 'Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': 'The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0\\*24)to 96 (4\\*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.'}, {'measure': 'Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases."}, {'measure': 'Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3,6, 9, and 12', 'description': "Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward."}, {'measure': 'Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 6 and 12', 'description': 'Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.'}, {'measure': 'Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': "Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases."}, {'measure': 'Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and 12', 'description': 'Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.'}, {'measure': 'Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)', 'timeFrame': 'Baseline to Weeks 3, 6, 9, and12', 'description': 'Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.'}, {'measure': 'Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)', 'timeFrame': 'Baseline to Week 12', 'description': 'BMI=Weight in kilograms /(Height in meters\\^2). LOCF=last observation carried forward.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder Mania']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key inclusion criteria:\n\n* Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features\n* Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole\n* Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline\n* Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.\n\nKey exclusion criteria:\n\n* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product\n* A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder\n* Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)\n* Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania\n* Thyroid pathology\n* Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.\n* History of neuroleptic malignant syndrome from antipsychotic agents\n* Manic symptoms that investigator considers refractory to treatment\n* Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms\n* Significant risk of suicide based on history, mental status exam, or investigator judgment."}, 'identificationModule': {'nctId': 'NCT00665366', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement', 'orgStudyIdInfo': {'id': 'CN138-502'}, 'secondaryIdInfos': [{'id': 'EudraCT number 2007-005959-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + valproate or lithium', 'description': 'Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Lithium', 'Drug: Valproate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aripiprazole + valproate or lithium', 'description': 'Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.', 'interventionNames': ['Drug: Aripiprazole', 'Drug: Lithium', 'Drug: Valproate']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify', 'BMS-337039'], 'description': '5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks', 'armGroupLabels': ['Aripiprazole + valproate or lithium']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, once daily, 12 weeks', 'armGroupLabels': ['Placebo + valproate or lithium']}, {'name': 'Lithium', 'type': 'DRUG', 'description': "Participant's ongoing dose", 'armGroupLabels': ['Aripiprazole + valproate or lithium', 'Placebo + valproate or lithium']}, {'name': 'Valproate', 'type': 'DRUG', 'description': "Participant's ongoing dose", 'armGroupLabels': ['Aripiprazole + valproate or lithium', 'Placebo + valproate or lithium']}]}, 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