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Pimavanserin for Insomnia in Veterans With PTSD — PIP-II  

Insomnia Clinical Trial

Official title:
Pimavanserin for Insomnia in Veterans With Post-traumatic Stress Disorder

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05441280
Study type Interventional
Source VA Office of Research and Development
Contact Melissa B Jones, MD
Phone (713) 794-1414
Email Melissa.Jones10@va.gov
Status Recruiting
Phase Phase 2
Start date June 26, 2023
Completion date July 12, 2027
View Details
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