RecruitingPhase 2NCT05441280

Pimavanserin for Insomnia in Veterans With PTSD

Pimavanserin for Insomnia in Veterans With Post-traumatic Stress Disorder


Sponsor

VA Office of Research and Development

Enrollment

60 participants

Start Date

Dec 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing pimavanserin, a medication already used for Parkinson's disease psychosis, to see if it can help veterans with PTSD who also have chronic insomnia (severe ongoing sleep problems). **You may be eligible if...** - You are a veteran aged 18 to 64 - You have been diagnosed with chronic insomnia disorder — trouble falling asleep, staying asleep, or waking too early, at least 3 nights a week for at least 3 months - Your insomnia is causing daytime problems - Your insomnia severity score is 15 or higher (moderate to severe insomnia) - You have clinically confirmed PTSD **You may NOT be eligible if...** - You have certain heart conditions or take certain medications that affect heart rhythm - You have a current diagnosis that makes the study drug unsafe for you - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpimavanserin

pimavanserin 34mg PO at bedtime

OTHERPlacebo

The placebo is a pill that looks like a study medication but has no medication in it


Locations(1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05441280


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