A Study of JZP150 in Adults With Posttraumatic Stress Disorder
NCT ID: NCT05178316
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2021-12-29
2023-12-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JZP150 0.3 mg
Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
JZP150
Oral administration of JZP150 once daily in the morning
JZP150 4.0 mg
Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
JZP150
Oral administration of JZP150 once daily in the morning
Placebo
Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
Placebo
Oral administration of placebo once daily in the morning
Interventions
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JZP150
Oral administration of JZP150 once daily in the morning
Placebo
Oral administration of placebo once daily in the morning
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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NoesisPharma LLC
Phoenix, Arizona, United States
Sanro Clinical Research Group, LLC
Bryant, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Clinical Innovations Inc.
Bellflower, California, United States
Southern California Research, LLC
Beverly Hills, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Excell Research
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
CITrials
Riverside, California, United States
Clinical Innovations Inc.
Santa Ana, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
MCB Clinical Research Center
Colorado Springs, Colorado, United States
CT Clinical Research
Cromwell, Connecticut, United States
Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
New Haven, Connecticut, United States
Howard University Hospital, Clinical Research Unit
Washington D.C., District of Columbia, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Accel Research Sites -Lakeland Clinical Research Unit
Lakeland, Florida, United States
Accel Research Sites Network-St. Petersburg Clinical Research Unit
Largo, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
EZY Medical Research Co
Miami, Florida, United States
Behavioral Clinical Research, Inc
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Advanced Discovery Research
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
American Medical Research, Inc
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Clinical Trial
Boston, Massachusetts, United States
Alivation Research, LLC
Lincoln, Nebraska, United States
Altea Research Institute
Las Vegas, Nevada, United States
Global Medical Institutes, LLC: Princeton Medical Institute
Princeton, New Jersey, United States
SPRI Clinical Trials
Brooklyn, New York, United States
Manhattan Behavioral Medicine
Manhattan, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, United States
Suburban Research Associates
West Chester, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Dell Medical School Universityof Texas at Austin
Austin, Texas, United States
Austin Clinical Trial Partners
Austin, Texas, United States
Houston Clinical Trials
Bellaire, Texas, United States
Relaro Medical Trials, LLC
Dallas, Texas, United States
Northpointe Psychiatry
Flower Mound, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Eastside Therapeutic Resource
Everett, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JZP150-201
Identifier Type: -
Identifier Source: org_study_id