Phase 3
Completed N=450
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Source: ClinicalTrials.gov NCT04124614 ↗Enrolled (actual)
450
Serious AEs
1.3%
Results posted
Jun 2025
Primary outcomePrimary: Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score — -19.19; -13.61 score on a scale — p=0.0007
◆ Published Evidence
Emerging
12citations · ~12 / year
Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial.
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.
Linked Publications
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Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score |
-19.19; -13.61 | 0.0007 sig |
| SECONDARY Change in Clinical Global Impression - Severity (CGI-S) Score |
-1.54; -1.08 | 0.0019 sig |
| SECONDARY Change in Brief Inventory or Psychosocial Functions (B-IPF) Score |
-33.80; -21.77 | 0.0016 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
Exclusion Criteria
- The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
- The index traumatic event occurred before age 16.
- Participants who have experienced a traumatic event within 3 months of screening.
- 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.
Data sourced from ClinicalTrials.gov (NCT04124614) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.