A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
Overview
- Phase
- Phase 2
- Intervention
- JZP150
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 282
- Locations
- 49
- Primary Endpoint
- Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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).
Detailed Description
JZP150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (FAAH). In this phase 2 study, participants with PTSD will receive either placebo or 1 of 2 doses of JZP150. The primary objective of the study will assess the change in PTSD symptoms from baseline to Week 12 using the Clinician Administered PTSD Scale (CAPS-5).
Investigators
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 \<3 months prior to Screening
- •Index event \> 12 years
- •Index event is combat trauma
Arms & Interventions
JZP150 0.3 mg
Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
Intervention: JZP150
JZP150 4.0 mg
Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
Intervention: JZP150
Placebo
Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
Time Frame: Baseline to Week 12
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome.
Secondary Outcomes
- Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)(Baseline to Week 12)
- Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)(Baseline to Week 12)