PTSD Clinical Trial
Official title:
A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
Verified date | October 2021 |
Source | Azevan Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 33 |
Est. completion date | March 31, 2021 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Medically stable, current diagnosis of PTSD Exclusion Criteria: - Medically unstable |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Azevan Pharmaceuticals | U.S. Army Medical Research and Development Command, United States Department of Defense, Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of overall clinical improvement | Measured using the Clinician Administered PTSD Scale (CAPS) | 18 weeks | |
Secondary | Number of participants with treatment-related adverse events | Assessments of adverse events (AEs), dose reductions and dropouts due to AEs | 18 weeks | |
Secondary | Reduction in depressive symptoms | Measured using the Beck Depression Inventory (BDI) | 18 weeks | |
Secondary | Reduction in anger and aggression | Measured using the Overt Aggression Scale-Modified (OAS-M) | 18 weeks | |
Secondary | Reduction in irritability | Measured using the Sheehan Irritability Scale (SIS) | 18 weeks | |
Secondary | Improvement in overall functioning | Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12) | 18 weeks | |
Secondary | Improvement in quality of life | Measured using the Sheehan Disability Scale (SDS) | 18 weeks | |
Secondary | Improvement in sleep quality | Measured using the Pittsburgh Sleep Quality Index (PSQI) | 18 weeks |
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