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

Completed · Phase 2 · Has a placebo group

Conditions studied: Stress Disorders, Post-Traumatic

In brief

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

Key facts

Study ID

NCT03033069

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

336

Starts

2017-01-26

Expected to finish

2018-11-12

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

You may not qualify if…

• Index trauma event >15 years before screening
• Index trauma event at age <16
• Any traumatic event within 3 months of screening

Where it is running

• 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
• Investigational Site — Orange, California, United States
• Investigational Site — Redlands, California, United States
• Investigational Site — Riverside, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — San Marcos, California, United States
• Investigational Site — Torrance, California, United States
• Investigational Site — Colorado Springs, Colorado, United States
• Investigational Site — Bradenton, Florida, United States
• Investigational Site — Fort Lauderdale, Florida, United States
• Investigational Site — Fort Myers, Florida, United States
• Investigational Site — Gainesville, Florida, United States
• Investigational Site — Jacksonville, Florida, United States
• Investigational Site — North Miami, Florida, United States
• Investigational Site — Orlando, Florida, United States
• Investigational Site — Orlando, Florida, United States
• Investigational Site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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