A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Phase 2

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
JZP150 0.3 mg	JZP150	Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
JZP150 4.0 mg	JZP150	Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
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. 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.

Secondary Outcome Measures

Name	Time	Method
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". Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome.
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". Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome.

Locations (49): NoesisPharma LLC
🇺🇸
Phoenix, Arizona, United States
Sanro Clinical Research Group, LLC
🇺🇸
Bryant, Arkansas, United States
Woodland Research Northwest
🇺🇸
Rogers, Arkansas, United States
Clinical Innovations Inc.
🇺🇸
Santa Ana, California, United States
Southern California Research, LLC
🇺🇸
Beverly Hills, California, United States
Behavioral Research Specialists, LLC
🇺🇸
Glendale, California, United States
Excell Research
🇺🇸
Oceanside, California, United States
NRC Research Institute
🇺🇸
Orange, California, United States
CITrials
🇺🇸
Riverside, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸
Torrance, California, United States
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NoesisPharma LLC
🇺🇸Phoenix, Arizona, United States