Overview

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

Status:
Terminated

Trial end date:
2021-03-31

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Azevan Pharmaceuticals

Collaborators:

U.S. Army Medical Research and Development Command
U.S. Army Medical Research and Materiel Command
United States Department of Defense
Weill Medical College of Cornell University

Treatments:

SRX246

Criteria

Inclusion Criteria:

- Medically stable, current diagnosis of PTSD

Exclusion Criteria:

- Medically unstable