A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Jazz Pharmaceuticals282 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

282

Conditions

Post Traumatic Stress Disorder

Interventions

JZP150DRUG

Oral administration of JZP150 once daily in the morning

PlaceboDRUG

Oral administration of placebo once daily in the morning

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (52)

Outcomes

Primary Outcomes

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. 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.

Time frame: Baseline to Week 12

Secondary Outcomes

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

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

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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