Clinical trial NCT05178316: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
JZP150
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NoesisPharma LLC
state: Arizona
city: Bryant
country: United States
facility: Sanro Clinical Research Group, LLC
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Innovations Inc.
state: California
city: Beverly Hills
country: United States
facility: Southern California Research, LLC
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Riverside
country: United States
facility: CITrials
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Center
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
state: Connecticut
city: Washington
country: United States
facility: Howard University Hospital, Clinical Research Unit
state: District of Columbia
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites -Lakeland Clinical Research Unit
state: Florida
city: Largo
country: United States
facility: Accel Research Sites Network-St. Petersburg Clinical Research Unit
state: Florida
city: Miami Lakes
country: United States
facility: Behavioral Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: EZY Medical Research Co
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Chicago
country: United States
facility: American Medical Research, Inc
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trial
state: Massachusetts
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Princeton
country: United States
facility: Global Medical Institutes, LLC: Princeton Medical Institute
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials
state: New York
city: Manhattan
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: West Chester
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Dell Medical School Universityof Texas at Austin
state: Texas
city: Austin
country: United States
facility: Austin Clinical Trial Partners
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials, LLC
state: Texas
city: Flower Mound
country: United States
facility: Northpointe Psychiatry
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Everett
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
References: