NCT04188392

Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder

Pilot Feasibility Study of Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.

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 study preliminary assesses the feasibility of pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.

Conditions

• Post-traumatic Stress Disorder
• Insomnia

Interventions

Type	Name	Description
DRUG	Pimavanserin	pimavanserin tablet

Timeline

• Start date: 2020-01-06
• Primary completion: 2021-10-27
• Completion: 2021-11-10
• First posted: 2019-12-05
• Last updated: 2022-08-31
• Results posted: 2022-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study