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

Phase 3 Completed 591 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2019-10-30
Primary completion: 2023-07-25
Completion: 2023-08-15

Publications

Davis LL, Behl S, Lee D, Zeng H, Skubiak T, Weaver S, Hefting N, Larsen KG, Hobart M. Fixed-Dose Brexpiprazole and Sertraline Combination Therapy for the Treatment of Posttraumatic Stress Disorder: A Phase 3, Randomized Trial. J Clin Psychopharmacol. 2025 Nov-Dec 01;45(6):580-589. doi: 10.1097/JCP.0000000000002076. Epub 2025 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	2 mg	Oral
Subject	Brexpiprazole	Small molecule	3 mg	Oral
Subject	Sertraline	Small molecule	150 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications