RecruitingPost-traumatic Stress DisorderInsomnia
Pimavanserin for Insomnia in Veterans With PTSD
Eligible age
18–64 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 1. Adult, male and female Veterans, aged 18-64;
- ✓ 2. At the initial enrollment visit, meets DSM-5 standards of chronic insomnia disorder, as follows:
- ✓ 1. Complains of dissatisfaction with nighttime sleep in the form of difficulty falling asleep (subjective sleep onset latency 30 minutes), difficulty staying asleep (subjective time awake after sleep onset 30 minutes), and/or awakening earlier in the morning ( 30 minutes before scheduled wake time and before a total sleep time of 6.5 hours) than desired;
- ✓ 2. Insomnia frequency of 3 times per week
- ✓ 3. The duration of the insomnia complaint is 3 months
- ✓ 4. Associated with complaint of daytime impairment;
- ✓ 3. Insomnia Severity Index (ISI) total score 15 (moderate insomnia);
- ✓ 4. Determined to have clinically significant PTSD symptoms as per the PTSD Checklist (PCL-5); a total score of 33 is a recommended cutoff for a diagnosis of PTSD;
You may not qualify if…
- ✕ 1. Current or a history of a primary psychotic disorder (i.e., schizophrenia, schizoaffective or bipolar disorder);
- ✕ 2. Active suicidal or homicidal ideation requiring crisis intervention;
- ✕ 3. Current moderate or severe alcohol or cannabis use disorder, or other illicit use disorder of any severity;
- ✕ 4. A history of moderate or severe traumatic brain injury or other neurological illness (i.e., stroke, epilepsy, multiple sclerosis);
- ✕ 5. Caffeine use that is deemed excessive and is contributing to the insomnia per the opinion of the investigators (e.g., caffeinated beverages consumed after 18:00 3 times/week and/or that correlates with the timing of the insomnia complaints);
- ✕ 6. Tobacco use before bedtime that is contributing to the insomnia per the opinion of the investigators or that would interfere with completing an overnight polysomnogram;
- ✕ 7. Previous diagnosis of periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, rapid eye movement sleep behavior disorder, or other sleep disorders (except obstructive sleep apnea) that may confound, per the opinion of the investigators, the assessment of insomnia;
- ✕ 8. Previous diagnosis of moderate to severe obstructive sleep apnea (defined as an apnea hypopnea index equal to or greater than 15 on home sleep test or attended polysomnography);
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT05441280 · last updated 2026-05-04