NCT05178316

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	JZP150	Oral administration of JZP150 once daily in the morning
DRUG	Placebo	Oral administration of placebo once daily in the morning

Timeline

• Start date: 2021-12-29
• Primary completion: 2023-12-05
• Completion: 2023-12-05
• First posted: 2022-01-05
• Last updated: 2024-12-31
• Results posted: 2024-12-31

Locations

52 sites across 1 country: United States

Regulatory

• FDA-regulated drug study