Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Summary

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

Timeline

Start

2019-10-30

Primary completion

2023-07-25

Completion

2023-08-15

Outcome

Missed primary endpoint

paper the primary endpoint was not met. PMID 40982703 ↗

paper LS mean differences (95% CI) versus sertraline+placebo at week 10: brexpiprazole 2 mg+sertraline, 1.03 (-2.09 to 4.16), P =0.52; PMID 40982703 ↗

release “The second phase 3 trial missed its primary endpoint (p>0.05).” otsuka-us.com ↗

release “In Trial 072, while the primary endpoint was not met” otsuka-us.com ↗

Publications

• Davis LL, Behl S, Lee D, Zeng H, Skubiak T, Weaver S, Hefting N, Larsen KG, Hobart M. Fixed-Dose Brexpiprazole and Sertraline Combination Therapy for the Treatment of Posttraumatic Stress Disorder: A Phase 3, Randomized Trial. J Clin Psychopharmacol. 2025 Nov-Dec 01;45(6):580-589. doi: 10.1097/JCP.0000000000002076. Epub 2025 Sep 22.

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