NCT04809116

Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept

Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a proof-of-concept, open-label trial of pimavanserin 34mg at bedtime for 6 weeks in Veterans with insomnia and Posttraumatic Stress Disorder.

Detailed description

More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder. There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep and insomnia. This proof-of-concept study preliminarily assesses the feasibility of open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.

Conditions

• Insomnia Chronic
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Pimavanserin	open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2021-03-22
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study