Trials / Terminated
TerminatedNCT02733614
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Azevan Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SRX246 | novel V1a receptor antagonist |
| DRUG | Placebo | matching placebo |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-10-01
- Completion
- 2021-03-31
- First posted
- 2016-04-11
- Last updated
- 2021-11-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02733614. Inclusion in this directory is not an endorsement.