Phase 2
Completed N=152
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Source: ClinicalTrials.gov NCT04044664 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores — -13.4; -15.7; -11.6; -4.4 units on a scale — p=0.1728
Summary
To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores |
-13.4; -15.7; -11.6; -4.4; -4.3; -3.7 | 0.1728 |
| SECONDARY PCL-5 (PTSD-Checklist for DSM-5) |
-16.6; -19.9; -17.0 | — |
| SECONDARY PSQI (Pittsburgh Sleep Quality Index) Global Score |
-1.5; -1.2; -1.8 | — |
| SECONDARY PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score |
-2.9; -1.9; -3.1 | — |
| SECONDARY BAC (Brief Assessment of Cognition) Symbol Coding |
3.8; 2.9; 1.3 | — |
| SECONDARY CGI-S (Clinical Global Impression - Severity) |
-1.1; -1.2; -1.3 | — |
| SECONDARY HADS-A (Hospital Anxiety and Depression Scale) |
-3.0; -4.4; -4.2 | 0.0452 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04044664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.