Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD).

Objective

To investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.

Design, setting, and participants

This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample).

Interventions

Oral brexpiprazole 2 to 3 mg per day (flexible dose)

SUBMITTER: Davis LL 

PROVIDER: S-EPMC11883513 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature