A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

Phase 2 Completed 336 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc. H. Lundbeck A/S · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.

Timeline

Start: 2017-01-26
Primary completion: 2018-11-12
Completion: 2018-11-12

Outcome

Met primary endpoint

registry analysis (superiority test); Brexpiprazole + Sertraline vs Placebo; p =0.0021; Least Squares (LS ) Mean Difference -5.99 (95% CI -9.79 to -2.19); NCT03033069 ↗

paper At Week 10, brexpiprazole + sertraline demonstrated greater improvement in CAPS-5 total score PMID 40009045 ↗

Publications

Hobart M, Chang D, Hefting N, Davis LL. Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial. J Clin Psychiatry. 2025 Feb 19;86(1):24m15577. doi: 10.4088/JCP.24m15577.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	1 mg	Oral
Subject	Brexpiprazole	Small molecule	3 mg	Oral
Subject	Sertraline	Small molecule	100 mg	Oral
Subject	Sertraline	Small molecule	200 mg	Oral