Pimavanserin for PTSD-Related Insomnia
(PIP-II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether pimavanserin, taken before bed, can reduce insomnia associated with post-traumatic stress disorder (PTSD). Participants will receive either the medication or a placebo (a pill with no active drug) to compare effects over eight weeks. The trial seeks veterans who experience insomnia at least three times a week for over three months and have noticeable PTSD symptoms affecting daily life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications before joining the trial. Specifically, hypnotics or sedating medications taken at bedtime, as well as some antipsychotics and antidepressants, must be stopped for 1 week before enrollment. However, you can continue taking SSRIs, SNRIs, bupropion, and some anticonvulsants if they have been stable for at least a month.
Is there any evidence suggesting that pimavanserin is likely to be safe for humans?
Research has shown that pimavanserin might be well-tolerated for treating sleep problems in people with PTSD. In an earlier study, patients who took 34 mg of pimavanserin at bedtime reported better sleep and fewer disturbances during the night, suggesting the treatment could be safe for this group.
Moreover, the FDA has already approved pimavanserin for treating certain symptoms in Parkinson's disease, such as hallucinations. This approval indicates that its safety has been studied in other conditions. While this does not eliminate the possibility of side effects, it suggests the treatment has undergone safety evaluation.12345Why do researchers think this study treatment might be promising for PTSD-related insomnia?
Pimavanserin is unique because it offers a novel approach to treating PTSD-related insomnia by targeting serotonin receptors in the brain, specifically the 5-HT2A receptors. Unlike typical treatments for PTSD-related insomnia, which often include benzodiazepines or other sedatives that can have addictive properties or cause drowsiness, pimavanserin has a different mechanism of action that may reduce these side effects. Researchers are excited about pimavanserin because it has the potential to improve sleep without the risks associated with other medications, offering a promising new option for those struggling with sleep disturbances related to PTSD.
What evidence suggests that pimavanserin might be an effective treatment for PTSD-related insomnia?
Research has shown that pimavanserin might help with sleep problems related to post-traumatic stress disorder (PTSD). In earlier studies, veterans who took 34mg of pimavanserin at bedtime reported better sleep and fewer disturbances during the night. These initial results suggest that pimavanserin could be a promising option for those with severe sleep issues due to PTSD. Participants in these studies generally tolerated the treatment well, experiencing few side effects. While more research is needed, these findings offer hope for improving sleep in people with PTSD-related insomnia. In this trial, participants will receive either pimavanserin or a placebo to further evaluate its effectiveness and safety.12346
Who Is on the Research Team?
Melissa B Jones, MD
Principal Investigator
Michael E. DeBakey VA Medical Center, Houston, TX
Are You a Good Fit for This Trial?
This trial is for male and female Veterans aged 18-64 with chronic insomnia and PTSD. Participants must meet specific sleep dissatisfaction criteria, have stable PTSD symptoms, not start other treatments during the study, and agree to contraception if applicable. Exclusions include psychotic disorders, substance abuse, certain brain injuries or neurological illnesses, some cardiovascular conditions, pregnancy or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pimavanserin 34mg or placebo at bedtime for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pimavanserin
- Placebo
Pimavanserin is already approved in United States for the following indications:
- Hallucinations and delusions associated with Parkinson's disease psychosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Industry Sponsor