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

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02733614
• Other study ID #: AVN010
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• PTSD

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