Pimavanserin for Insomnia in Veterans With PTSD

This study is looking at whether pimavanserin (Nuplazid) can help Veterans who have both post-traumatic stress disorder (PTSD) and insomnia (trouble falling or staying asleep). Pimavanserin is a medication approved for other conditions, and this study will see if it can improve sleep for Veterans with PTSD. You would receive either pimavanserin 34mg or a placebo (a pill with no medicine) once a day at bedtime for 8 weeks. The main goal is to see how your sleep quality changes, measured by the Insomnia Severity Index (ISI). This study is for adult Veterans, aged 18-64, who meet specific criteria for chronic insomnia disorder. The study is currently unclear on its recruitment status.

Study design
This is a preliminary randomized, double-blind, placebo-controlled study involving 60 participants.
What's involved
Participants will take either pimavanserin 34mg or a placebo at bedtime for 8 weeks. They will also complete sleep studies and wear actigraphy watches.
Compensation
Not stated in the trial record.
Follow-up
Your sleep quality will be measured at 8 weeks post-randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05441280

Pimavanserin for Insomnia in Veterans With PTSD

Recruiting
PHASE2Ages 18–64InterventionalTreatment
VA Office of Research and Development
~60 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:pimavanserinPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over 8 weeks post-randomization
Post-traumatic Stress Disorder
Insomnia
1 sites across 1 states
Texas1
  • Melissa B Jones, MD · PRINCIPAL_INVESTIGATOR · Michael E. DeBakey VA Medical Center, Houston, TX

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  • Insomnia Severity Index (ISI)8 weeks post-randomization

    Mean change in ISI total score at 8-weeks in active vs. placebo groups