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CompletedPhase 2

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Key facts

Who runs it
Jazz Pharmaceuticals
Where
Atlanta, Austin, Bellaire, Bellflower, Beverly Hills, Boston, Brooklyn, Bryant, Chicago, Colorado Springs, Cromwell, Dallas, Dayton, Decatur, Everett, Flower Mound, Gainesville, Glendale, Jacksonville, Lakeland, Largo, Las Vegas, Lincoln, Manhattan, Memphis, Miami, Miami Lakes, Middleburg Heights, New Haven, North Canton, Oceanside, Oklahoma City, Orange, Orlando, Phoenix, Princeton, Richardson, Riverside, Rochester, Rogers, San Antonio, Santa Ana, Staten Island, Torrance, Upland, Washington D.C., West Chester, and Wichita Falls, United StatesSee the 52 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
282 people enrolled
Started
29 Dec 2021
Ended
5 Dec 2023
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • JZP150
  • Placebo
Record updated
31 December 2024

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
  • Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
  • Index event > 12 years
  • Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
  • Index event is combat trauma

Where in United States

  • Advanced Discovery ResearchAtlanta, United States
  • Austin Clinical Trial PartnersAustin, United States
  • Dell Medical School Universityof Texas at AustinAustin, United States
  • Houston Clinical TrialsBellaire, United States
  • Clinical Innovations, Inc.Bellflower, United States
  • Southern California Research, LLCBeverly Hills, United States
  • Boston Clinical TrialBoston, United States
  • Brigham and Women's HospitalBoston, United States
  • SPRI Clinical TrialsBrooklyn, United States
  • Sanro Clinical Research Group, LlcBryant, United States
  • American Medical Research, Inc.Chicago, United States
  • MCB Clinical Research CenterColorado Springs, United States
  • CT Clinical ResearchCromwell, United States
  • Relaro Medical Trials, LLCDallas, United States
  • Midwest Clinical Research CenterDayton, United States
  • CenExel iResearchDecatur, United States
  • Eastside Therapeutic ResourceEverett, United States
  • Northpointe PsychiatryFlower Mound, United States
  • Sarkis Clinical TrialsGainesville, United States
  • Behavioral Research Specialists, LLCGlendale, United States
  • Clinical NeuroScience Solutions IncJacksonville, United States
  • Accel Research Sites - Lakeland Clinical Research UnitLakeland, United States
  • Accel Research Sites Network-St. Petersburg Clinical Research UnitLargo, United States
  • Altea Research InstituteLas Vegas, United States
  • Alivation Research, LLCLincoln, United States
  • Manhattan Behavioral MedicineManhattan, United States
  • Clinical Neuroscience Solutions, Inc.Memphis, United States
  • Ezy Medical Research Co.Miami, United States
  • Premier Clinical Research InstituteMiami, United States
  • Behavioral Clinical Research, Inc.Miami Lakes, United States
  • North Star Medical Research, LLCMiddleburg Heights, United States
  • Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)New Haven, United States
  • Neuro-Behavioral Clinical Research Inc.North Canton, United States
  • Excell ResearchOceanside, United States
  • IPS Research CompanyOklahoma City, United States
  • Paradigm Research Professionals, LLCOklahoma City, United States
  • NRC Research InstituteOrange, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • NoesisPharma, LLCPhoenix, United States
  • Global Medical Institutes LLC; Princeton Medical InstitutePrinceton, United States
  • Pillar Clinical Research, LLCRichardson, United States
  • CITrialsRiverside, United States
  • Finger Lakes Clinical ResearchRochester, United States
  • Woodland Research NorthwestRogers, United States
  • Clinical Trials of TexasSan Antonio, United States
  • Clinical Innovations Inc.Santa Ana, United States
  • Richmond Behavioral AssociatesStaten Island, United States
  • Collaborative Neuroscience Research LLCTorrance, United States
  • Pacific Clinical Research Management Group LLCUpland, United States
  • Howard University Hospital, Clinical Research UnitWashington D.C., United States
  • Suburban Research AssociatesWest Chester, United States
  • Grayline Research CenterWichita Falls, United States

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • JZP150 0.3 mgTreatment being tested

    Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.

    Treatment: JZP150

  • JZP150 4.0 mgTreatment being tested

    Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.

    Treatment: JZP150

  • PlaceboPlacebo, for comparison

    Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
Record updated
31 December 2024