Work

Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Objective: To investigate the efficacy, safety, and tolerability of brexpiprazole in combination with sertraline and as monotherapy for posttraumatic stress disorder (PTSD). Methods:The trial comprised a 1-week placebo run-in period followed by an 11-week, randomized, double-blind, active-referenced, placebo-controlled, parallel-arm treatment period (with 14-day follow-up).The trial ran from January 2017-November 2018 at 48 clinical trial sites in the United States.Adult outpatients with PTSD (DSM-5) were randomized (1:1:1:1) to oral brexpiprazole + sertraline, brexpiprazole + placebo, sertraline + placebo, or placebo + placebo.Doses were flexible (brexpiprazole 1-3 mg/d; sertraline 100-200 mg/d).The primary endpoint was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from randomization (Week 1) to Week 10.Safety assessments included adverse events.Results: Among 321 randomized participants, completion rates were 58/82 (70.7%) for brexpiprazole + sertraline, 50/75 (66.7%) for brexpiprazole + placebo, 59/81 (72.8%) for sertraline + placebo, and 64/83 (77.1%) for placebo + placebo.At Week 10, brexpiprazole + sertraline demonstrated greater improvement in CAPS-5 total score (randomization, 35.7; least-squares [LS] mean change, -16.4; n = 77) vs sertraline + placebo (randomization, 36.5;LS mean change, -11.4; n = 75) with LS mean difference, -5.08 (95% CI, -8.96 to -1.20; P = .011),and also vs brexpiprazole + placebo and vs placebo + placebo.Brexpiprazole + placebo and sertraline + placebo did not differ from placebo + placebo.Treatmentemergent adverse events with incidence ≥10% were weight increased (12.5%) and somnolence (10.0%) for brexpiprazole + sertraline, akathisia (13.3%) for brexpiprazole + placebo, and nausea (20.3%) and dry mouth (12.7%) for sertraline + placebo.Conclusions: Brexpiprazole in combination with sertraline (but not as monotherapy) has potential to be a new efficacious treatment for PTSD, with a safety profile consistent with brexpiprazole in approved indications.

Source: The Journal of Clinical Psychiatry

DOI: 10.4088/jcp.24m15577

Authors: Mary Hobart, Denise Chang, Nanco Hefting, Lori L. Davis

Institutions: Otsuka (United States), Otsuka Pharmaceutical Development & Commercialization, Inc. (United States), Lundbeck (Denmark), University of Alabama at Birmingham, UAB Medicine

Language: English

Topic: Posttraumatic Stress Disorder Research

Subfield: Clinical Psychology

Field: Psychology

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: Otsuka Pharmaceutical, H. Lundbeck A/S