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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02733614
Other study ID # AVN010
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2016
Est. completion date March 31, 2021

Study information

Verified date October 2021
Source Azevan Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SRX246
novel V1a receptor antagonist
Placebo
matching placebo

Locations

Country Name City State
United States Weill Cornell Medical College New York New York

Sponsors (4)

Lead Sponsor Collaborator
Azevan Pharmaceuticals U.S. Army Medical Research and Development Command, United States Department of Defense, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

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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