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

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).

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: JZP150; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • NoesisPharma LLC
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Sanro Clinical Research Group, Llc
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Bellflower, California, United States, 90706
      • Clinical Innovations Inc.
    • Beverly Hills, California, United States, 90210
      • Southern California Research, LLC
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Oceanside, California, United States, 92056
      • Excell Research
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Riverside, California, United States, 92506
      • CiTrials
    • Santa Ana, California, United States, 90705
      • Clinical Innovations Inc.
    • Torrance, California, United States, 90504
      • Collaborative Neuroscience Research, LLC
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Center
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research
    • New Haven, Connecticut, United States, 06519
      • Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University Hospital, Clinical Research Unit
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Lakeland, Florida, United States, 33803
      • Accel Research Sites -Lakeland Clinical Research Unit
    • Largo, Florida, United States, 33777
      • Accel Research Sites Network-St. Petersburg Clinical Research Unit
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute
    • Miami, Florida, United States, 33175
      • EZY Medical Research Co
    • Miami Lakes, Florida, United States, 33016
      • Behavioral Clinical Research, Inc
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Advanced Discovery Research
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch
  • Illinois
    • Chicago, Illinois, United States, 60612
      • American Medical Research, Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trial
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institutes, LLC: Princeton Medical Institute
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials
    • Manhattan, New York, United States, 10036
      • Manhattan Behavioral Medicine
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals, LLC
  • Pennsylvania
    • West Chester, Pennsylvania, United States, 19380
      • Suburban Research Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78712
      • Dell Medical School Universityof Texas at Austin
    • Austin, Texas, United States, 78737
      • Austin Clinical Trial Partners
    • Bellaire, Texas, United States, 77401
      • Houston Clinical Trials
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials, LLC
    • Flower Mound, Texas, United States, 75028
      • Northpointe Psychiatry
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Washington
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JZP150 0.3 mg; Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.	Drug: JZP150; Oral administration of JZP150 once daily in the morning
Experimental: JZP150 4.0 mg; Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.	Drug: JZP150; Oral administration of JZP150 once daily in the morning
Placebo Comparator: Placebo; Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.	Drug: Placebo; Oral administration of placebo once daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)	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.	Baseline to Week 12
Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)	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.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Post Traumatic Stress Disorder; JZP150
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: JZP150-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No