NCT03033069

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD. This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole oral tablets.
DRUG	Sertraline	Sertraline oral capsules.
DRUG	Brexpiprazole Matching Placebo	Brexpiprazole matching placebo oral tablets.
DRUG	Sertraline Matching Placebo	Sertraline matching placebo oral capsules.

Timeline

• Start date: 2017-01-26
• Primary completion: 2018-11-12
• Completion: 2018-11-12
• First posted: 2017-01-26
• Last updated: 2021-12-08
• Results posted: 2021-12-08

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated drug study