NCT05441280

Pimavanserin for Insomnia in Veterans With PTSD

Pimavanserin for Insomnia in Veterans With Post-traumatic Stress Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a preliminary randomized, double-blind, placebo-controlled trial comparing pimavanserin 34mg at bedtime vs. placebo for the treatment of insomnia associated with post-traumatic stress disorder.

Detailed description

Veterans with post-traumatic stress disorder (PTSD) frequently have insomnia (trouble falling or staying asleep). Untreated insomnia carries grave health consequences. Early evidence suggests that pimavanserin (Nuplazid), a medication approved by the Food and Drug Administration for the treatment of psychosis (hallucinations and delusions) in Parkinson's Disease, may treat insomnia. In this preliminary study, Veterans with insomnia and PTSD will receive either pimavanserin 34mg or placebo at bedtime for 8 weeks, and sleep quality will be compared pre- and post-treatment. Veterans will also complete sleep studies and wear actigraphy watches so we may better appreciate how pimavanserin impacts sleep. Overall, this study will help us understand pimavanserin's potential benefit for treating PTSD-related insomnia and prepare for a larger, future trial.

Conditions

• Post-traumatic Stress Disorder
• Insomnia

Interventions

Type	Name	Description
DRUG	pimavanserin	pimavanserin 34mg PO at bedtime
OTHER	Placebo	The placebo is a pill that looks like a study medication but has no medication in it

Timeline

• Start date: 2023-12-28
• Primary completion: 2027-07-12
• Completion: 2027-07-12
• First posted: 2022-07-01
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study