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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
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Investigational Site
Tuscaloosa, Alabama, United States
Investigational Site
Phoenix, Arizona, United States
Investigational Site
Little Rock, Arkansas, United States
Investigational Site
Rogers, Arkansas, United States
Investigational Site
Bellflower, California, United States
Investigational Site
Beverly Hills, California, United States
Investigational Site
Glendale, California, United States
Investigational Site
National City, California, United States
Investigational Site
Oceanside, California, United States
Investigational Site
Oceanside, California, United States
Start Date
January 26, 2017
Primary Completion Date
November 12, 2018
Completion Date
November 12, 2018
Last Updated
December 8, 2021
336
ACTUAL participants
Brexpiprazole
DRUG
Sertraline
DRUG
Brexpiprazole Matching Placebo
DRUG
Sertraline Matching Placebo
DRUG
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
NCT05674617
NCT06000475
NCT03887559
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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