Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

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 fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

Key facts

Study ID

NCT04174170

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

591

Starts

2019-10-30

Expected to finish

2023-08-15

Last updated by the study team

2025-05-30

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 post-traumatic stress disorder (PTSD), diagnosed according to 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 development 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 — New York, New York, United States

Full record on ClinicalTrials.gov

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