PTSD
Conditions
Brief summary
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)
Interventions
DRUGNYX-783
NYX-783
DRUGPlacebo
Placebo for 50 mg NYX-783
Sponsors
Worldwide Clinical Trials
Aptinyx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PTSD (DSM-5 criteria) * Stable allowed medications with no planned changes from 30 days prior to screening through study participation * Willing to use highly effective birth control * Willing to comply with protocol visits and procedures
Exclusion criteria
* Moderate to severe traumatic brain injury * Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders * Substance use disorder or alcohol use disorder within 6 months prior to screening * Psychotherapy or cognitive based therapy within 30 days prior to screening * Use of investigational drug within 30 days prior to screening * Prior participation in study of NYX-783, NYX-2925 or NYX-458.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition) | study endpoint, up to 10 weeks | Change from Baseline in CAPS-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-S (Clinician Global Impression - Severity) | study endpoint, up to 10 weeks | Change from Baseline in CGI-S |
| PGI-S (Patient Global Impression - Severity) | study endpoint, up to 10 weeks | Change from Baseline in PGI-S |
| SDS (Sheehan Disability Scale) | study endpoint, up to 10 weeks | Change from Baseline in SDS |
Countries
United States
Outcome results
None listed