A Study of JZP150 in Adults With Posttraumatic Stress Disorder
A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
1 other identifier
interventional
282
1 country
52
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2021
CompletedStudy Start
First participant enrolled
December 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2023
CompletedResults Posted
Study results publicly available
December 31, 2024
CompletedDecember 31, 2024
December 1, 2024
1.9 years
December 8, 2021
December 5, 2024
December 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
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.
Baseline to Week 12
Secondary Outcomes (2)
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
Study Arms (3)
JZP150 0.3 mg
EXPERIMENTALParticipants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
JZP150 4.0 mg
EXPERIMENTALParticipants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
Placebo
PLACEBO COMPARATORParticipants who will be randomized to receive placebo orally once daily for up to 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
NoesisPharma LLC
Phoenix, Arizona, 85016, United States
Sanro Clinical Research Group, LLC
Bryant, Arkansas, 72022, United States
Woodland Research Northwest
Rogers, Arkansas, 72758, United States
Clinical Innovations Inc.
Bellflower, California, 90706, United States
Southern California Research, LLC
Beverly Hills, California, 90210, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Excell Research
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
CITrials
Riverside, California, 92506, United States
Clinical Innovations Inc.
Santa Ana, California, 90705, United States
Collaborative Neuroscience Research, LLC
Torrance, California, 90504, United States
Pacific Clinical Research Management Group LLC
Upland, California, 91786, United States
MCB Clinical Research Center
Colorado Springs, Colorado, 80910, United States
CT Clinical Research
Cromwell, Connecticut, 06416, United States
Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
New Haven, Connecticut, 06519, United States
Howard University Hospital, Clinical Research Unit
Washington D.C., District of Columbia, 20060, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Accel Research Sites -Lakeland Clinical Research Unit
Lakeland, Florida, 33803, United States
Accel Research Sites Network-St. Petersburg Clinical Research Unit
Largo, Florida, 33777, United States
Premier Clinical Research Institute
Miami, Florida, 33122, United States
EZY Medical Research Co
Miami, Florida, 33175, United States
Behavioral Clinical Research, Inc
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Advanced Discovery Research
Atlanta, Georgia, 30318, United States
CenExel iResearch
Decatur, Georgia, 30030, United States
American Medical Research, Inc
Chicago, Illinois, 60612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Clinical Trial
Boston, Massachusetts, 02131, United States
Alivation Research, LLC
Lincoln, Nebraska, 68526, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Global Medical Institutes, LLC: Princeton Medical Institute
Princeton, New Jersey, 08540, United States
SPRI Clinical Trials
Brooklyn, New York, 11235, United States
Manhattan Behavioral Medicine
Manhattan, New York, 10036, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, 44720, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118, United States
Suburban Research Associates
West Chester, Pennsylvania, 19380, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Dell Medical School Universityof Texas at Austin
Austin, Texas, 78712, United States
Austin Clinical Trial Partners
Austin, Texas, 78737, United States
Houston Clinical Trials
Bellaire, Texas, 77401, United States
Relaro Medical Trials, LLC
Dallas, Texas, 75243, United States
Northpointe Psychiatry
Flower Mound, Texas, 75028, United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Grayline Research Center
Wichita Falls, Texas, 76309, United States
Eastside Therapeutic Resource
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure & Transparency
- Organization
- Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
January 5, 2022
Study Start
December 29, 2021
Primary Completion
December 5, 2023
Study Completion
December 5, 2023
Last Updated
December 31, 2024
Results First Posted
December 31, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.