Status:
COMPLETED
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Lead Sponsor:
Aptinyx
Collaborating Sponsors:
Premier Research
Massachusetts General Hospital
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.
Detailed Description
The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up P...
Eligibility Criteria
Inclusion
- A primary diagnosis of PTSD \[Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)\] with the primary traumatic event occurring ≥12 months prior to screening.
- PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
- CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.
Exclusion
- Complex PTSD.
- Trauma focused psychotherapies.
- Primary traumatic event occurred prior to 2001.
- Primary traumatic event was followed by further major traumatic life episodes.
- Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
- Current use of medications with primarily central nervous system activities
- Other clinically significant medical histories that may interfere with completing the study.
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04044664
Start Date
January 25 2019
End Date
August 5 2020
Last Update
May 17 2022
Active Locations (37)
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1
Aptinyx Clinical Site
Tuscaloosa, Alabama, United States, 35404
2
Aptinyx Clinical Site
Phoenix, Arizona, United States, 85012
3
Aptinyx Clinical Site
Little Rock, Arkansas, United States, 30322
4
Aptinyx Clinical Site
Bellflower, California, United States, 90706