Phase 2
Completed N=277
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
Source: ClinicalTrials.gov NCT05178316 ↗Enrolled (actual)
277
Serious AEs
1.4%
Results posted
Dec 2024
Primary outcomePrimary: Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score — -17.0; -17.8; -17.6 score on a scale — p==0.8862
Summary
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score |
-17.0; -17.8; -17.6 | =0.8862 |
| SECONDARY Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) |
-1.4; -1.3; -1.2 | =0.4522 |
| SECONDARY Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) |
-1.0; -1.1; -1.0 | =0.7170 |
Eligibility Criteria
Inclusion Criteria
- Participants aged 18 to 70 years
- Participants must be outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defined PTSD confirmed by the clinical interview
- PTSD is primary diagnosis
Exclusion Criteria
- Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
- Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
- Ongoing traumatic event or exposure to a traumatic event 12 years
- Index event is combat trauma
Data sourced from ClinicalTrials.gov (NCT05178316). 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.