Fixed-Dose Brexpiprazole and Sertraline Combination Therapy for the Treatment of Posttraumatic Stress Disorder: A Phase 3, Randomized Trial.

ABSTRACT:

Purpose

This trial aimed to investigate the efficacy, safety, and tolerability of fixed-dose brexpiprazole in combination with sertraline for posttraumatic stress disorder (PTSD).

Methods

This was a phase 3, randomized, parallel-arm trial in adult outpatients with PTSD, across 95 sites in the United States (ClinicalTrials.gov: NCT04174170). After a 1-week placebo run-in, participants entered 11 weeks of randomized (1:1:1) double-blind treatment with brexpiprazole 2 mg/d+sertraline 150 mg/d, brexpiprazole 3 mg/d+sertraline 150 mg/d, or sertraline 150 mg/d+placebo (active control). The primary endpoint was the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from randomization (week 1) to week 10. Safety was also assessed.

Findings

The trial (O

SUBMITTER: Davis LL 

PROVIDER: S-EPMC12573675 | biostudies-literature | 2025 Nov-Dec 01

REPOSITORIES: biostudies-literature