Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : Suspended (COVID-19)
First Posted : April 11, 2016
Last Update Posted : June 18, 2020
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

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
Assessment of overall clinical improvement [ Time Frame: 18 weeks ]
Measured using the Clinician Administered PTSD Scale (CAPS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Number of participants with treatment-related adverse events [ Time Frame: 18 weeks ]
    Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
  • Reduction in depressive symptoms [ Time Frame: 18 weeks ]
    Measured using the Beck Depression Inventory (BDI)
  • Reduction in anger and aggression [ Time Frame: 18 weeks ]
    Measured using the Overt Aggression Scale-Modified (OAS-M)
  • Reduction in irritability [ Time Frame: 18 weeks ]
    Measured using the Sheehan Irritability Scale (SIS)
  • Improvement in overall functioning [ Time Frame: 18 weeks ]
    Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
  • Improvement in quality of life [ Time Frame: 18 weeks ]
    Measured using the Sheehan Disability Scale (SDS)
  • Improvement in sleep quality [ Time Frame: 18 weeks ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
Official Title  ICMJE A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Drug: SRX246
    novel V1a receptor antagonist
  • Drug: Placebo
    matching placebo
Study Arms  ICMJE
  • Experimental: SRX246
    SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks
    Intervention: Drug: SRX246
  • Placebo Comparator: Placebo
    oral administration, capsules, daily for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 5, 2016)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Medically stable, current diagnosis of PTSD

Exclusion Criteria:

  • Medically unstable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733614
Other Study ID Numbers  ICMJE AVN010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Azevan Pharmaceuticals
Study Sponsor  ICMJE Azevan Pharmaceuticals
Collaborators  ICMJE
  • Weill Medical College of Cornell University
  • United States Department of Defense
  • U.S. Army Medical Research and Development Command
Investigators  ICMJE Not Provided
PRS Account Azevan Pharmaceuticals
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP