Status:
COMPLETED
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 Pos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04124614
Start Date
October 17 2019
End Date
August 8 2023
Last Update
June 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding sites, contact 844-687-8522
San Diego, California, United States, 92103