Phase 2
Completed N=321
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Stress Disorders, Post-Traumatic
Source: ClinicalTrials.gov NCT03033069 ↗
Enrolled (actual)
321
Serious AEs
2.2%
Results posted
Dec 2021
Primary outcomePrimary: 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 — -16.4; -12.2; -11.4; -10.5 score on a scale — p==0.0021
Summary
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-16.4; -12.2; -11.4; -10.5 | =0.0021 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)
Exclusion Criteria
- Index trauma event >15 years before screening
- Index trauma event at age <16
- Any traumatic event within 3 months of screening
Data sourced from ClinicalTrials.gov (NCT03033069). 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.