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Completed

NCT Number: NCT05178316

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

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).

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NoesisPharma LLC, Phoenix, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JZP150

Drug

Oral administration of JZP150 once daily in the morning

Placebo

Drug

Oral administration of placebo once daily in the morning

Primary outcomes

  1. Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score

    Time frame: 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 outcomes

  1. Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)

    Time frame: 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.

  2. Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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