Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02733614
Recruitment Status : Terminated (funding)
First Posted : April 11, 2016
Last Update Posted : November 1, 2021
Sponsor:
Collaborators:
Weill Medical College of Cornell University
United States Department of Defense
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Azevan Pharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
PTSD Drug: SRX246 Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2020
Actual Study Completion Date : March 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessment of overall clinical improvement [ Time Frame: 18 weeks ]
    Measured using the Clinician Administered PTSD Scale (CAPS)


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 18 weeks ]
    Assessments of adverse events (AEs), dose reductions and dropouts due to AEs

  2. Reduction in depressive symptoms [ Time Frame: 18 weeks ]
    Measured using the Beck Depression Inventory (BDI)

  3. Reduction in anger and aggression [ Time Frame: 18 weeks ]
    Measured using the Overt Aggression Scale-Modified (OAS-M)

  4. Reduction in irritability [ Time Frame: 18 weeks ]
    Measured using the Sheehan Irritability Scale (SIS)

  5. Improvement in overall functioning [ Time Frame: 18 weeks ]
    Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)

  6. Improvement in quality of life [ Time Frame: 18 weeks ]
    Measured using the Sheehan Disability Scale (SDS)

  7. Improvement in sleep quality [ Time Frame: 18 weeks ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically stable, current diagnosis of PTSD

Exclusion Criteria:

  • Medically unstable
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733614


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Azevan Pharmaceuticals
Weill Medical College of Cornell University
United States Department of Defense
U.S. Army Medical Research and Development Command
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Azevan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02733614    
Other Study ID Numbers: AVN010
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
SRX246
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs