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

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

Outcome

Met primary endpoint

paper brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score PMID 39693081 ↗

paper LS mean difference, -5.59 (95% CI, -8.79 to -2.38; P < .001). PMID 39693081 ↗

release “The first trial met its primary endpoint by demonstrating improvements from baseline on the primary endpoint of CAPS-5” otsuka-us.com ↗

release “In Trial 071, the least squares mean change was -19.2 with brexpiprazole in combination with sertraline (p=0.0007 versus sertraline plus placebo)” otsuka-us.com ↗

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

Indications