A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: JZP150
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JZP150 0.3 mg<br>Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. | Drug: JZP150<br>* Oral administration of JZP150 once daily in the morning<br>|
| Experimental: JZP150 4.0 mg<br>Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. | Drug: JZP150<br>* Oral administration of JZP150 once daily in the morning<br>|
| Placebo Comparator: Placebo<br>Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. | Drug: Placebo<br>* Oral administration of placebo once daily in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 12 | 
| 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. | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder, JZP150