A Study of JZP150 in Adults With Posttraumatic Stress Disorder
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Drug: PlaceboDrug: JZP150
- Registration Number
- NCT05178316
- Lead Sponsor
- Jazz Pharmaceuticals
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. JZP150 0.3 mg JZP150 Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. JZP150 4.0 mg JZP150 Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score 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 Outcome Measures
Name Time Method Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Baseline to Week 12 Clinical Global Impression of Severity (CGI-S) is a clinician assessment used to assess the severity of the participants' PTSD on a scale range of 1 to 7, where 1 indicates "normal, not at all ill" and a 7 indicates "among the most extremely ill participants".
Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome.Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Baseline to Week 12 Patient Global Impression of Severity (PGI-S) is a patient assessment designed to evaluate severity of PTSD symptoms on a scale from 1 to 5, where 1 indicates "none" and 5 indicates "very severe".
Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome.
Trial Locations
- Locations (49)
Clinical Innovations Inc.
🇺🇸Santa Ana, California, United States
Global Medical Institutes, LLC: Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Premier Clinical Research Institute
🇺🇸Miami, Florida, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Howard University Hospital, Clinical Research Unit
🇺🇸Washington, District of Columbia, United States
Collaborative Neuroscience Research, LLC
🇺🇸Torrance, California, United States
Behavioral Clinical Research, Inc
🇺🇸Miami Lakes, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Southern California Research, LLC
🇺🇸Beverly Hills, California, United States
CenExel iResearch
🇺🇸Decatur, Georgia, United States
Alivation Research, LLC
🇺🇸Lincoln, Nebraska, United States
EZY Medical Research Co
🇺🇸Miami, Florida, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Excell Research
🇺🇸Oceanside, California, United States
Pacific Clinical Research Management Group LLC
🇺🇸Upland, California, United States
Accel Research Sites Network-St. Petersburg Clinical Research Unit
🇺🇸Largo, Florida, United States
Advanced Discovery Research
🇺🇸Atlanta, Georgia, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Houston Clinical Trials
🇺🇸Bellaire, Texas, United States
Eastside Therapeutic Resource
🇺🇸Everett, Washington, United States
SPRI Clinical Trials
🇺🇸Brooklyn, New York, United States
American Medical Research, Inc
🇺🇸Chicago, Illinois, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Northpointe Psychiatry
🇺🇸Flower Mound, Texas, United States
Suburban Research Associates
🇺🇸West Chester, Pennsylvania, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
NoesisPharma LLC
🇺🇸Phoenix, Arizona, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Sanro Clinical Research Group, LLC
🇺🇸Bryant, Arkansas, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
NRC Research Institute
🇺🇸Orange, California, United States
CITrials
🇺🇸Riverside, California, United States
MCB Clinical Research Center
🇺🇸Colorado Springs, Colorado, United States
Accel Research Sites -Lakeland Clinical Research Unit
🇺🇸Lakeland, Florida, United States
Boston Clinical Trial
🇺🇸Boston, Massachusetts, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸North Canton, Ohio, United States
Paradigm Research Professionals, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Manhattan Behavioral Medicine
🇺🇸Manhattan, New York, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
🇺🇸New Haven, Connecticut, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Austin Clinical Trial Partners
🇺🇸Austin, Texas, United States
Dell Medical School Universityof Texas at Austin
🇺🇸Austin, Texas, United States