PIMAVANSERIN FOR INSOMNIA IN VETERANS WITH PTSD
About Study
The purpose of the PIP study is to learn whether Veterans with Post-Traumatic Stress Disorder (PTSD) and trouble falling or staying asleep may benefit from a medication called pimavanserin.
This medication has been approved by the Food and Drug Administration for patients with Parkinson’s Disease who have psychosis, but it may also help improve sleep in patients with PTSD. We are interested in understanding whether pimavanserin at bedtime for 8 weeks is a practical and welltolerated medication to treat insomnia in Veterans with active PTSD.
Participation involves attending six visits in-person at the Michael E. DeBakey VA. Visits include clinical interviews, answering questionnaires, taking measurements of your height, weight and other vitals, and checking your blood and your urine.Three of the visits involve sleeping overnight in the sleep lab at the Michael E. DeBakey VA before and after taking the medication. In addition, participation involves filling out a sleep diary and wearing a watch at home for 7 days before and 7 days after taking the medication. The total length of the study is 14 weeks.
Participants may receive up to $630 for your time and efforts. You may also be eligible for additional assessments and treatment studies. You may qualify for this study if:
- You are a Veteran between the ages of 18 to 64
- You have difficulty falling or staying asleep
- You currently have PTSD
- You do not have a history of certain sleep or neurological disorders
- You are not taking certain medications
Your participation in this study is completely voluntary, and your choice regarding participation will not affect the health care you receive at the VA. If you do not wish to be contacted again about this study, please return the enclosed postcard. If we do not receive your reply within 14 days, a team member may send you another letter and/or contact you by phone.
Please take time to learn more about this research opportunity. Your participation can help us improve the future of our military, both active and retired. If you would like to talk to us directly, please call the research team at (713) 794-1414 ext. 24747.