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

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ClinicalTrials.gov Identifier: NCT02733614
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically stable, current diagnosis of PTSD

Exclusion Criteria:

  • Medically unstable
Contacts and Locations

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

Contact: Andrew McAleavey, PhD 212-821-0711 anm9256@med.cornell.edu
Contact: Neal G Simon, PhD 610-419-1057 ngsimon@azevan.com

United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Andrew McAleavey, PhD    212-821-0711    anm9256@med.cornell.edu   
Principal Investigator: JoAnn Difede, PhD         
Sponsors and Collaborators
Azevan Pharmaceuticals
Weill Medical College of Cornell University
United States Department of Defense
U.S. Army Medical Research and Materiel Command
More Information

Responsible Party: Azevan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02733614     History of Changes
Other Study ID Numbers: AVN010
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs