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A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Primary Purpose

Post Traumatic Stress Disorder

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JZP150
Placebo
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, JZP150

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NoesisPharma LLC
  • Sanro Clinical Research Group, LLC
  • Woodland Research Northwest
  • Clinical Innovations Inc.
  • Southern California Research, LLC
  • Behavioral Research Specialists, LLC
  • Excell Research
  • NRC Research Institute
  • CITrials
  • Clinical Innovations Inc.
  • Collaborative Neuroscience Research, LLC
  • Pacific Clinical Research Management Group LLC
  • MCB Clinical Research Center
  • CT Clinical Research
  • Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
  • Howard University Hospital, Clinical Research Unit
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Accel Research Sites -Lakeland Clinical Research Unit
  • Accel Research Sites Network-St. Petersburg Clinical Research Unit
  • Behavioral Clinical Research, Inc
  • Premier Clinical Research Institute
  • EZY Medical Research Co
  • Clinical Neuroscience Solutions, Inc.
  • Advanced Discovery Research
  • CenExel iResearch
  • American Medical Research, Inc
  • Brigham and Women's Hospital
  • Boston Clinical Trial
  • Alivation Research, LLC
  • Altea Research Institute
  • Global Medical Institutes, LLC: Princeton Medical Institute
  • SPRI Clinical Trials
  • Manhattan Behavioral Medicine
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates
  • Midwest Clinical Research Center
  • North Star Medical Research, LLC
  • Neuro-Behavioral Clinical Research, Inc
  • IPS Research Company
  • Paradigm Research Professionals, LLC
  • Suburban Research Associates
  • Clinical Neuroscience Solutions, Inc.
  • Dell Medical School Universityof Texas at Austin
  • Austin Clinical Trial Partners
  • Houston Clinical Trials
  • Relaro Medical Trials, LLC
  • Northpointe Psychiatry
  • Pillar Clinical Research, LLC
  • Clinical Trials of Texas
  • Grayline Research Center
  • Eastside Therapeutic Resource

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

JZP150 0.3 mg

JZP150 4.0 mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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 range from 0 to 5, where 0 indicates the symptoms are "absent" and 5 indicates the symptoms are "extreme/incapacitating".

Secondary Outcome Measures

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".
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".

Full Information

First Posted
December 8, 2021
Last Updated
August 15, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05178316
Brief Title
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Post Traumatic Stress Disorder, JZP150

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JZP150 0.3 mg
Arm Type
Experimental
Arm Description
Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
Arm Title
JZP150 4.0 mg
Arm Type
Experimental
Arm Description
Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
JZP150
Intervention Description
Oral administration of JZP150 once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of placebo once daily in the morning
Primary Outcome Measure Information:
Title
Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
Description
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".
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Description
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".
Time Frame
Baseline to Week 12
Title
Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
Description
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".
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NoesisPharma LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Sanro Clinical Research Group, LLC
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Woodland Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Clinical Innovations Inc.
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Southern California Research, LLC
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CITrials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Clinical Innovations Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
90705
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90504
Country
United States
Facility Name
Pacific Clinical Research Management Group LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
MCB Clinical Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Howard University Hospital, Clinical Research Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Accel Research Sites -Lakeland Clinical Research Unit
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Accel Research Sites Network-St. Petersburg Clinical Research Unit
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Behavioral Clinical Research, Inc
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Premier Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
EZY Medical Research Co
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Advanced Discovery Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
CenExel iResearch
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
American Medical Research, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Clinical Trial
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Global Medical Institutes, LLC: Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
SPRI Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
Manhattan
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Suburban Research Associates
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Dell Medical School Universityof Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Austin Clinical Trial Partners
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Houston Clinical Trials
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Relaro Medical Trials, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Northpointe Psychiatry
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of JZP150 in Adults With Posttraumatic Stress Disorder

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