{"protocolSection":{"identificationModule":{"nctId":"NCT04174170","orgStudyIdInfo":{"id":"331-201-00072"},"organization":{"fullName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","class":"INDUSTRY"},"briefTitle":"Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder","officialTitle":"A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder"},"statusModule":{"statusVerifiedDate":"2025-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-07-25","type":"ACTUAL"},"completionDateStruct":{"date":"2023-08-15","type":"ACTUAL"},"studyFirstSubmitDate":"2019-11-21","studyFirstSubmitQcDate":"2019-11-21","studyFirstPostDateStruct":{"date":"2019-11-22","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-05-12","resultsFirstSubmitQcDate":"2025-05-28","resultsFirstPostDateStruct":{"date":"2025-05-30","type":"ACTUAL"},"dispFirstSubmitDate":"2024-07-23","dispFirstPostDateStruct":{"date":"2025-05-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-05-28","lastUpdatePostDateStruct":{"date":"2025-05-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder."},"conditionsModule":{"conditions":["Post Traumatic Stress Disorder"],"keywords":["PTSD"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":591,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period.","interventionNames":["Other: Placebo"]},{"label":"Brexpiprazole (2 mg) + Sertraline","type":"EXPERIMENTAL","description":"Randomized participants received brexpiprazole 2 milligrams (mg), orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.","interventionNames":["Drug: Sertraline","Drug: Brexpiprazole"]},{"label":"Brexpiprazole (3 mg) + Sertraline","type":"EXPERIMENTAL","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period.","interventionNames":["Drug: Brexpiprazole","Drug: Sertraline"]},{"label":"Sertraline + Placebo","type":"EXPERIMENTAL","description":"Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.","interventionNames":["Drug: Sertraline","Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Brexpiprazole","description":"3 mg pill","armGroupLabels":["Brexpiprazole (3 mg) + Sertraline"],"otherNames":["Rexulti"]},{"type":"DRUG","name":"Sertraline","description":"150 mg pill","armGroupLabels":["Brexpiprazole (2 mg) + Sertraline","Brexpiprazole (3 mg) + Sertraline","Sertraline + Placebo"],"otherNames":["Zoloft"]},{"type":"OTHER","name":"Placebo","description":"Pill","armGroupLabels":["Placebo","Sertraline + Placebo"]},{"type":"DRUG","name":"Brexpiprazole","description":"2 mg pill","armGroupLabels":["Brexpiprazole (2 mg) + Sertraline"],"otherNames":["Rexulti"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score","description":"CAPS-5 was a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by DSM-5. CAPS -5 total score 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 range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","timeFrame":"Baseline (Week 1), Week 10"}],"secondaryOutcomes":[{"measure":"Change in Clinical Global Impression - Severity (CGI-S) Score","description":"The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: \"Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?\" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The score 0 (not assessed) was to be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","timeFrame":"Baseline (Week 1), Week 10"},{"measure":"Change in Brief Inventory of Psychosocial Functions (B-IPF) Score","description":"The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. The B-IPF measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","timeFrame":"Baseline, Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.\n* Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).\n* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.\n\nExclusion Criteria:\n\n* The index traumatic event that led to the development of PTSD took place \\> 9 years before screening.\n* The index traumatic event occurred before age 16.\n* Participants who have experienced a traumatic event within 3 months of screening.\n* Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"For additional information regarding sites, contact 844-687-8522","city":"New York","state":"New York","zip":"10010","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"references":[{"pmid":"40982703","type":"DERIVED","citation":"Davis LL, Behl S, Lee D, Zeng H, Skubiak T, Weaver S, Hefting N, Larsen KG, Hobart M. Fixed-Dose Brexpiprazole and Sertraline Combination Therapy for the Treatment of Posttraumatic Stress Disorder: A Phase 3, Randomized Trial. J Clin Psychopharmacol. 2025 Nov-Dec 01;45(6):580-589. doi: 10.1097/JCP.0000000000002076. Epub 2025 Sep 22."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.","infoTypes":["STUDY_PROTOCOL","CSR"],"timeFrame":"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.","accessCriteria":"Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com","url":"https://clinical-trials.otsuka.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with a diagnosis of post-traumatic stress disorder (PTSD) were first enrolled in a 1-week placebo run-in period. At the end of placebo run-in period, participants were randomized in a 1:1:1 ratio to receive a combination of Brexpiprazole (2 \\[milligrams\\]mg/day) + Sertraline, Brexpiprazole (3 mg/day) + Sertraline or Sertraline + Placebo in the double-blind treatment (DBT) period.","recruitmentDetails":"A total of 591 participants took part in the study at 75 investigative sites in the United States from 30 October 2019 to 15 August 2023.","groups":[{"id":"FG000","title":"Placebo","description":"All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period."},{"id":"FG001","title":"Brexpiprazole (2 mg) + Sertraline","description":"Randomized participants received brexpiprazole 2 mg, orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"FG002","title":"Brexpiprazole (3 mg) + Sertraline","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"FG003","title":"Sertraline + Placebo","description":"Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period."}],"periods":[{"title":"Placebo Run-in Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"591"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"553"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Not Randomized","reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Double Blind Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"191"},{"groupId":"FG002","numSubjects":"185"},{"groupId":"FG003","numSubjects":"177"}]},{"type":"Randomized Sample","comment":"Randomized Sample included all participants randomized into this trial.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"191"},{"groupId":"FG002","numSubjects":"185"},{"groupId":"FG003","numSubjects":"177"}]},{"type":"Enriched Randomized Sample","comment":"Enriched Randomized Sample included all participants who were randomized satisfying Enriched Participants Criteria, where Enriched Participants Criteria: Clinician-Administered PTSD Scale for Diagnostic \\& Statistical Manual of Mental Disorders,5th edition \\[DSM-5\\] (CAPS-5) total score of at least 27 at randomization visit (Week 1),\\& an improvement (reduction in CAPS-5 total score)in CAPS-5 total score of less than 50% at end of placebo run-in phase (from baseline to randomization visit \\[Week 1\\]).","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"143"},{"groupId":"FG002","numSubjects":"136"},{"groupId":"FG003","numSubjects":"138"}]},{"type":"Full Analysis Set (FAS) Enriched Sample","comment":"FAS for Enriched Participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind investigational medicinal product (IMP), had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"132"},{"groupId":"FG002","numSubjects":"126"},{"groupId":"FG003","numSubjects":"130"}]},{"type":"Safety Sample","comment":"Safety Sample included all participants in the randomized sample who were administered at least one dose of double-blind IMP.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"185"},{"groupId":"FG002","numSubjects":"180"},{"groupId":"FG003","numSubjects":"172"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"126"},{"groupId":"FG002","numSubjects":"123"},{"groupId":"FG003","numSubjects":"116"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"62"},{"groupId":"FG003","numSubjects":"61"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"8"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"25"}]},{"type":"Non-Compliance With Study Drug","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"14"}]},{"type":"Reason Not Specified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Randomized Sample included all participants randomized into this trial.","groups":[{"id":"BG000","title":"Brexpiprazole (2 mg) + Sertraline","description":"Randomized participants received brexpiprazole 2 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"BG001","title":"Brexpiprazole (3 mg) + Sertraline","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"BG002","title":"Sertraline + Placebo","description":"Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"37.1","spread":"12.1"},{"groupId":"BG001","value":"36.3","spread":"11.7"},{"groupId":"BG002","value":"37.7","spread":"12.3"},{"groupId":"BG003","value":"37.0","spread":"12.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"141"},{"groupId":"BG002","value":"126"},{"groupId":"BG003","value":"409"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"144"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Hispanic or Latino","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"122"}]}]},{"title":"Not Hispanic or Latino","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"143"},{"groupId":"BG001","value":"146"},{"groupId":"BG002","value":"140"},{"groupId":"BG003","value":"429"}]}]},{"title":"Unknown","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"Other","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"130"},{"groupId":"BG001","value":"124"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"375"}]}]},{"title":"Black or African American","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"135"}]}]},{"title":"American Indian or Alaska Native","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"6"}]}]},{"title":"Asian","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"19"}]}]},{"title":"Native Hawaiian or Other Pacific Islander","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}]}]},{"title":"Other","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"177"},{"groupId":"BG003","value":"553"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"15"}]}]}]},{"title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score","description":"CAPS-5 was structured interview to assess PTSD diagnostic status \\& symptoms severity as defined by DSM-5. CAPS-5 total score=sum of 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 \\& mood symptoms (7 items); Category E: Arousal \\& 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 score range 0-80. Higher scores indicate worse outcome.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"130"},{"groupId":"BG003","value":"388"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"38.8","spread":"8.3"},{"groupId":"BG001","value":"37.8","spread":"7.3"},{"groupId":"BG002","value":"39.3","spread":"7.8"},{"groupId":"BG003","value":"38.7","spread":"7.8"}]}]}]},{"title":"Clinical Global Impression - Severity (CGI-S) Score","description":"CGI-S=standardized clinician-administered global rating scale measuring disease severity. To assess CGI-S, rater/investigator answered following question:\"Considering your total clinical experience with this particular population,how mentally ill is participant at this time?\"Response choices include:0=not assessed; 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; \\& 7=among most extremely ill participants. Score 0 (not assessed) was to be set to missing. CGI-S is a 7-point scale from 1-7. Higher score =higher disease severity.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Number of participants analyzed is the number of participants with data available for CGI-S score at the Baseline.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"124"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"385"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.6","spread":"0.7"},{"groupId":"BG001","value":"4.5","spread":"0.7"},{"groupId":"BG002","value":"4.7","spread":"0.7"},{"groupId":"BG003","value":"4.6","spread":"0.7"}]}]}]},{"title":"Brief Inventory of Psychosocial Functions (B-IPF) Score","description":"The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. The B-IPF measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Number of participants analyzed is the number of participants with data available for B-IPF score at the Baseline.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"125"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"367"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"63.3","spread":"20.1"},{"groupId":"BG001","value":"62.5","spread":"22.4"},{"groupId":"BG002","value":"59.9","spread":"20.5"},{"groupId":"BG003","value":"61.9","spread":"21.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score","description":"CAPS-5 was a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by DSM-5. CAPS -5 total score 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 range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline (Week 1), Week 10","groups":[{"id":"OG000","title":"Brexpiprazole (2 mg) + Sertraline","description":"Randomized participants received brexpiprazole 2 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG001","title":"Brexpiprazole (3 mg) + Sertraline","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG002","title":"Sertraline + Placebo","description":"Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"130"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.53","spread":"1.19"},{"groupId":"OG001","value":"-18.28","spread":"1.23"},{"groupId":"OG002","value":"-17.57","spread":"1.19"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5165","statisticalMethod":"MMRM","paramType":"Treatment Difference","paramValue":"1.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.09","ciUpperLimit":"4.16"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6593","statisticalMethod":"MMRM","paramType":"Treatment Difference","paramValue":"-0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.88","ciUpperLimit":"2.46"}]},{"type":"SECONDARY","title":"Change in Clinical Global Impression - Severity (CGI-S) Score","description":"The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: \"Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?\" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The score 0 (not assessed) was to be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline (Week 1), Week 10","groups":[{"id":"OG000","title":"Brexpiprazole (2 mg) + Sertraline","description":"Randomized participants received brexpiprazole 2 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG001","title":"Brexpiprazole (3 mg) + Sertraline","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG002","title":"Sertraline + Placebo","description":"Participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.26","spread":"0.10"},{"groupId":"OG001","value":"-1.31","spread":"0.11"},{"groupId":"OG002","value":"-1.29","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8215","pValueComment":"MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.","statisticalMethod":"MMRM","paramType":"Treatment Difference","paramValue":"0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.31"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8584","pValueComment":"MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.","statisticalMethod":"MMRM","paramType":"Treatment Difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.26"}]},{"type":"SECONDARY","title":"Change in Brief Inventory of Psychosocial Functions (B-IPF) Score","description":"The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. The B-IPF measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.","populationDescription":"FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 12","groups":[{"id":"OG000","title":"Brexpiprazole (2 mg) + Sertraline","description":"Randomized participants received brexpiprazole 2 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG001","title":"Brexpiprazole (3 mg) + Sertraline","description":"Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period."},{"id":"OG002","title":"Sertraline + Placebo","description":"Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT 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