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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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 subjects with Post-Traumatic Stress Disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Brexpiprazole; Sertraline

Criteria

Inclusion Criteria:

• Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.

• Subjects who have PTSD, diagnosed according to 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.

• Subjects who have experienced a traumatic event within 3 months of screening.

• Subjects 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.