Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT04124614

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

450

Starts

2019-10-17

Expected to finish

2023-08-08

Last updated by the study team

2025-06-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• For additional information regarding sites, contact 844-687-8522 — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.