NCT04124614

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

A Phase 3, Multicenter, Randomized, Double-blind Trial of 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: 450 (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 brexpiprazole + sertraline combination treatment in adult participants 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

Timeline

• Start date: 2019-10-17
• Primary completion: 2023-07-19
• Completion: 2023-08-08
• First posted: 2019-10-11
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study