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A Study of JZP150 in Adults With Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05178316
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: JZP150 Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 29, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score [ Time Frame: 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 range from 0 to 5, where 0 indicates the symptoms are "absent" and 5 indicates the symptoms are "extreme/incapacitating".


Secondary Outcome Measures :
  1. Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) [ Time Frame: 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".

  2. Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) [ Time Frame: 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".



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178316


Contacts
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Contact: Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Jazz Pharmaceuticals
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05178316    
Other Study ID Numbers: JZP150-201-01
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
Post Traumatic Stress Disorder
JZP150
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders