At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 591 enrolled
Drug / intervention
Brexpiprazole +3 moredrug
Likely dose
Brexpiprazole 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 22, 2019·Updated May 30, 2025
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole, Sertraline, and 1 other intervention for Post Traumatic Stress Disorder. Completed, enrolled 591 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Traumatic Stress Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartOct 2019
First PostedNov 2019
Primary CompletionJul 2023
Study CompletionAug 2023
TodayJul 2026
First PostedNov 22, 2019
Enrollment StartOct 30, 2019
Primary CompletionJul 25, 2023
Study CompletionAug 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.6 years ago
Interventions
Brexpiprazoledrug
3 mg pill
Sertralinedrug
150 mg pill
Placeboother
Pill
Brexpiprazoledrug
2 mg pill