At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
Brexpiprazole +2 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 Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 11, 2019·Updated Jun 13, 2025
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole, Sertraline, and 1 other intervention for Post Traumatic Stress Disorder. Completed, enrolled 450 participants across 1 site.
Detailed Summary
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Traumatic Stress Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionJul 2023
Study CompletionAug 2023
TodayJul 2026
First PostedOct 11, 2019
Enrollment StartOct 17, 2019
Primary CompletionJul 19, 2023
Study CompletionAug 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.7 years ago
Interventions
Brexpiprazoledrug
3 mg pill
Sertralinedrug
150 mg pill
Placeboother
Pill