Overview

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jazz Pharmaceuticals
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