Actively Recruiting
Pimavanserin for Insomnia in Veterans With PTSD
Led by VA Office of Research and Development · Updated on 2026-05-04
60
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pimavanserin for Insomnia in Veterans With PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male and female Veterans aged 18 to 64 years
- Meets DSM-5 criteria for chronic insomnia disorder with difficulty falling or staying asleep or early awakening
- Insomnia symptoms occur at least 3 times per week for at least 3 months
- Daytime impairment related to insomnia
- Insomnia Severity Index total score of 15 or higher indicating moderate insomnia
- Clinically significant PTSD symptoms with a PTSD Checklist (PCL-5) total score of 33 or higher
- Willing and able to follow all study procedures
- Willing to avoid starting other behavioral or treatment programs for insomnia, PTSD, or psychiatric disorders during the study
- Women of child-bearing potential must agree to use acceptable contraception or abstain from sexual activity during the study
- Stable doses of certain psychiatric medications (SSRIs, SNRIs, bupropion, anticonvulsants excluding strong CYP3A4 inhibitors/inducers) for at least 1 month prior to study entry
You will not qualify if you...
- Current or past diagnosis of primary psychotic disorders such as schizophrenia, schizoaffective, or bipolar disorder
- Active suicidal or homicidal thoughts requiring crisis intervention
- Moderate to severe alcohol or cannabis use disorder or any other illicit drug use disorder
- History of moderate or severe traumatic brain injury or neurological illnesses like stroke, epilepsy, or multiple sclerosis
- Excessive caffeine use contributing to insomnia
- Tobacco use before bedtime contributing to insomnia or interfering with overnight sleep study
- Diagnosis of certain sleep disorders excluding obstructive sleep apnea which may confound insomnia assessment
- Moderate to severe obstructive sleep apnea or high risk for it based on screening questionnaires or sleep studies
- Prolonged QT interval on ECG
- Recent use of cognitive behavioral therapy for insomnia or PTSD therapies that may interfere with assessment
- Significant medical illnesses that could affect safety or study assessments
- Pregnant or breastfeeding women
- Women of childbearing potential not using acceptable pregnancy prevention
- Conditions increasing risk of sudden death or torsades de pointes
- Use of hypnotics, sedating medications, antipsychotics, or antidepressants with 5-HT2A antagonist activity within 1 week prior to enrollment
- Use of strong CYP3A4 inhibitors or inducers
- Concurrent use of medications known to increase QT interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
Research Team
M
Melissa B Jones, MD
CONTACT
R
Ricardo E Jorge, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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