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

October 25, 2021 updated by: Azevan Pharmaceuticals

A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically stable, current diagnosis of PTSD

Exclusion Criteria:

  • Medically unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SRX246
SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks
Drug: SRX246
novel V1a receptor antagonist
PLACEBO_COMPARATOR: Placebo
oral administration, capsules, daily for 8 weeks
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of overall clinical improvement
Time Frame: 18 weeks
Measured using the Clinician Administered PTSD Scale (CAPS)
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 18 weeks
Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
18 weeks
Reduction in depressive symptoms
Time Frame: 18 weeks
Measured using the Beck Depression Inventory (BDI)
18 weeks
Reduction in anger and aggression
Time Frame: 18 weeks
Measured using the Overt Aggression Scale-Modified (OAS-M)
18 weeks
Reduction in irritability
Time Frame: 18 weeks
Measured using the Sheehan Irritability Scale (SIS)
18 weeks
Improvement in overall functioning
Time Frame: 18 weeks
Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
18 weeks
Improvement in quality of life
Time Frame: 18 weeks
Measured using the Sheehan Disability Scale (SDS)
18 weeks
Improvement in sleep quality
Time Frame: 18 weeks
Measured using the Pittsburgh Sleep Quality Index (PSQI)
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azevan Pharmaceuticals

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVN010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe