Pimavanserin for Insomnia in Veterans With Post-traumatic Stress Disorder
VA Office of Research and Development
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.
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 com…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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…
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
Location
- Michael E. DeBakey VA Medical Center, Houston, TXHouston, Texas