Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 65
Start Date:December 2016
End Date:June 2018
Contact:Andrew McAleavey, PhD

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A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to
assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and
civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a
double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246
for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for
8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period
between treatments. Subjects will be assessed at baseline and then every 2 weeks during the
trial using the CAPS.

Inclusion Criteria:

- Medically stable, current diagnosis of PTSD

Exclusion Criteria:

- Medically unstable
We found this trial at
New York, New York 10021
Principal Investigator: JoAnn Difede, PhD
Phone: 212-821-0711
New York, NY
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