NCT04174170

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

A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Brexpiprazole	3 mg pill
DRUG	Sertraline	150 mg pill
OTHER	Placebo	Pill
DRUG	Brexpiprazole	2 mg pill

Timeline

• Start date: 2019-10-30
• Primary completion: 2023-07-25
• Completion: 2023-08-15
• First posted: 2019-11-22
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study