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

• Status: Completed
• Trial end date: 2018-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Brexpiprazole; Sertraline

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Index trauma event >15 years before screening

• Index trauma event at age <16

• Any traumatic event within 3 months of screening