A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05178316
Collaborator
(none)
270
22
3
17.1
12.3
0.7

Study Details

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).

Condition or Disease Intervention/Treatment Phase
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).

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 29, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

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 [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) [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) [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Altea Research Phoenix Arizona United States 85012
2 Clinical Innovations Inc. Bellflower California United States 90706
3 Southern California Research, LLC Beverly Hills California United States 90210
4 Behavioral Research Specialists, LLC Glendale California United States 91206
5 Excell Research Oceanside California United States 92056
6 CITrials Riverside California United States 92506
7 Clinical Innovations Inc. Santa Ana California United States 90705
8 Sarkis Clinical Trials Gainesville Florida United States 32607
9 Behavioral Clinical Research, Inc Miami Lakes Florida United States 33016
10 Premier Clinical Research Institute Miami Florida United States 33122
11 EZY Medical Research Co Miami Florida United States 33175
12 Boston Clinical Trial Boston Massachusetts United States 02131
13 Alivation Research, LLC Lincoln Nebraska United States 68526
14 Global Medical Institutes, LLC: Princeton Medical Institute Princeton New Jersey United States 08540
15 Finger Lakes Clinical Research Rochester New York United States 14618
16 Richmond Behavioral Associates Staten Island New York United States 10312
17 Midwest Clinical Research Center Dayton Ohio United States 45417
18 Neuro-Behavioral Clinical Research, Inc North Canton Ohio United States 44720
19 Austin Clinical Trial Partners Austin Texas United States 78737
20 Pillar Clinical Research, LLC Richardson Texas United States 75080
21 Clinical Trials of Texas San Antonio Texas United States 78229
22 Grayline Research Center Wichita Falls Texas United States 76309

Sponsors and Collaborators

  • Jazz Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05178316
Other Study ID Numbers:
  • JZP150-201-01
First Posted:
Jan 5, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jazz Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022