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



Status:Completed
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:1/6/2019
Start Date:January 2017
End Date:November 8, 2018

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole 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 (Zoloft) 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
subjects with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day
follow-up.

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
We found this trial at
51
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28207
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Colorado Springs, Colorado 80910
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National City, California 91950
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