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

Phase 3 Completed 450 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 brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.

Timeline

Start: 2019-10-17
Primary completion: 2023-07-19
Completion: 2023-08-08

Publications

Davis LL, Behl S, Lee D, Zeng H, Skubiak T, Weaver S, Hefting N, Larsen KG, Hobart M. Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial. JAMA Psychiatry. 2025 Mar 1;82(3):218-227. doi: 10.1001/jamapsychiatry.2024.3996.

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 Treatment of Adults With PTSD

Summary

Timeline

Publications

Drugs

Indications