Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/22/2017 |
| Start Date: | December 2016 |
| End Date: | June 2018 |
| Contact: | Andrew McAleavey, PhD |
| Email: | anm9256@med.cornell.edu |
| Phone: | 212-821-0711 |
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.
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
1
site
New York, New York 10021
Principal Investigator: JoAnn Difede, PhD
Phone: 212-821-0711
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