Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-30 @ 10:57 PM
Study NCT ID:
NCT03033069
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591922', 'term': 'brexpiprazole'}, {'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltransparency@otsuka-us.com', 'phone': '1-609-524-6788', 'title': 'Global Clinical Development', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of the study drug up to 14 days after the last dose (Up to Week 14)', 'description': 'Safety Sample included all participants who were randomized into this trial and were administered at least one dose of double-blind IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'Brexpiprazole + Sertraline', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 47, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Brexpiprazole', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 42, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Sertraline', 'description': 'Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 46, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 43, 'seriousNumAtRisk': 82, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Weight increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Anorgasmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Delayed ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole + Sertraline', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'OG001', 'title': 'Brexpiprazole', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.'}, {'id': 'OG002', 'title': 'Sertraline', 'description': 'Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '-11.4', 'spread': '1.46', 'groupId': 'OG002'}, {'value': '-10.5', 'spread': '1.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '=0.0021', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares (LS ) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.99', 'ciLowerLimit': '-9.79', 'ciUpperLimit': '-2.19', 'groupDescription': 'MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.3868', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-5.70', 'ciUpperLimit': '2.22', 'groupDescription': 'MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6399', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-4.74', 'ciUpperLimit': '2.92', 'groupDescription': 'MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0106', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.08', 'ciLowerLimit': '-8.96', 'ciUpperLimit': '-1.20', 'groupDescription': 'MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.24', 'ciLowerLimit': '-8.26', 'ciUpperLimit': '-0.23', 'groupDescription': 'MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Sample included all participants who were randomized in the trial and took at least one dose of double-blind investigational medicinal product (IMP) and have a Baseline and at least one post Baseline evaluation for the CAPS-5 total score. Overall number of participants analyzed are the number of participants with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brexpiprazole + Sertraline', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'FG001', 'title': 'Brexpiprazole', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.'}, {'id': 'FG002', 'title': 'Sertraline', 'description': 'Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '83'}]}, {'type': 'Safety Sample', 'comment': 'Safety Sample included all participants who were randomized into this trial and were administered at least one dose of double-blind investigational medicinal product (IMP).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '82'}]}, {'type': 'Intent to Treat (ITT) Sample', 'comment': 'ITT Sample included all participants who were randomized in the trial and took at least one dose of double-blind IMP and have a Baseline and at least one post Baseline evaluation for the clinician-administered PTSD scale for diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) CAPS-5 total score.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal By Caregiver', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 48 investigative sites in the United States from 26 January 2017 to 12 November 2018.', 'preAssignmentDetails': 'Of the 336 participants enrolled in the study, 321 participants diagnosed with post-traumatic stress disorder (PTSD) were randomized in 1:1:1:1 ratio to receive brexpiprazole monotherapy, brexpiprazole plus sertraline combination therapy, sertraline monotherapy or placebo up to Week 12.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '321', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Brexpiprazole + Sertraline', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'BG001', 'title': 'Brexpiprazole', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.'}, {'id': 'BG002', 'title': 'Sertraline', 'description': 'Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week12.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '39.2', 'spread': '11.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '321', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Sample included all participants randomized into this trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-08', 'size': 7437635, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-08T09:49', 'hasProtocol': True}, {'date': '2018-11-07', 'size': 6230318, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-08T09:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2019-10-09', 'completionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2017-01-24', 'dispFirstSubmitQcDate': '2021-11-10', 'resultsFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2017-01-24', 'dispFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-10', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score', 'timeFrame': 'Baseline, Week 12', 'description': 'CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '40009045', 'type': 'DERIVED', 'citation': 'Hobart M, Chang D, Hefting N, Davis LL. Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial. J Clin Psychiatry. 2025 Feb 19;86(1):24m15577. doi: 10.4088/JCP.24m15577.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.', 'detailedDescription': 'This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD.\n\nThis study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)\n\nExclusion Criteria:\n\n* Index trauma event \\>15 years before screening\n* Index trauma event at age \\<16\n* Any traumatic event within 3 months of screening'}, 'identificationModule': {'nctId': 'NCT03033069', 'briefTitle': 'A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder', 'orgStudyIdInfo': {'id': '331-201-00061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brexpiprazole + Sertraline', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.', 'interventionNames': ['Drug: Brexpiprazole', 'Drug: Sertraline', 'Drug: Sertraline Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brexpiprazole', 'description': 'Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.', 'interventionNames': ['Drug: Brexpiprazole', 'Drug: Sertraline Matching Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline', 'description': 'Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.', 'interventionNames': ['Drug: Sertraline', 'Drug: Brexpiprazole Matching Placebo', 'Drug: Sertraline Matching Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.', 'interventionNames': ['Drug: Brexpiprazole Matching Placebo', 'Drug: Sertraline Matching Placebo']}], 'interventions': [{'name': 'Brexpiprazole', 'type': 'DRUG', 'otherNames': ['OPC-34712', 'OPC-331'], 'description': 'Brexpiprazole oral tablets.', 'armGroupLabels': ['Brexpiprazole', 'Brexpiprazole + Sertraline']}, {'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': 'Sertraline oral capsules.', 'armGroupLabels': ['Brexpiprazole + Sertraline', 'Sertraline']}, {'name': 'Brexpiprazole Matching Placebo', 'type': 'DRUG', 'description': 'Brexpiprazole matching placebo oral tablets.', 'armGroupLabels': ['Placebo', 'Sertraline']}, {'name': 'Sertraline Matching Placebo', 'type': 'DRUG', 'description': 'Sertraline matching placebo oral capsules.', 'armGroupLabels': ['Brexpiprazole', 'Brexpiprazole + Sertraline', 'Placebo', 'Sertraline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 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