Reduce hallucinations without worsening movement
- Trial ID
- NCT04373317
- Official Title
- CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
- Goal
- Reduce hallucinations without worsening movement
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- INTERVENTIONAL
- Enrollment
- 358 participants
- Conditions
- Parkinson's Disease Psychosis
- Interventions
- Pimavanserin, Quetiapine
Plain-Language Summary
The goal is to see which antipsychotic better reduces hallucinations and delusions in people with Parkinson's, while minimizing worsening of movement or other side effects. It compares pimavanserin, which works as a serotonin 5-HT2A inverse agonist so it can reduce psychosis without blocking dopamine receptors and usually does not interfere with levodopa, to quetiapine, an atypical antipsychotic that blocks dopamine and serotonin receptors and can help psychosis but may cause sedation or worsen parkinsonism at higher doses. The study is looking for English-speaking veterans age 40 and older with Parkinson's and significant psychosis who are on stable PD medications and have a regular caregiver or "informed other" to attend visits, while excluding people with certain heart rhythm problems, recent high-dose antipsychotic use, dementia with Lewy bodies, or other serious medical issues.
Locations
- Southern Arizona VA Health Care System, Tucson, AZ, Tucson, Arizona, United States
- VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States
- VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States
- San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States
- Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States
- North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, United States
- Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States
- Lexington VA Medical Center, Lexington, KY, Lexington, Kentucky, United States
- VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States
- Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis, Missouri, United States
- New Mexico VA Health Care System, Albuquerque, NM, Albuquerque, New Mexico, United States
- Syracuse VA Medical Center, Syracuse, NY, Syracuse, New York, United States
- Asheville VA Medical Center, Asheville, NC, Asheville, North Carolina, United States
- Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States
- VA Portland Health Care System, Portland, OR, Portland, Oregon, United States
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States
- Philadelphia MultiService Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, United States
And 4 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Pimavanserin. The goal is to see which antipsychotic better reduces hallucinations and delusions in people with Parkinson's, while minimizing worsening of movement or other side effects. It compares pimavanserin, which works as a serotonin 5-HT2A inverse agonist so it can reduce psychosis without blocking dopamine receptors and usually does not interfere with levodopa, to quetiapine, an atypical antipsychotic that blocks dopamine and serotonin receptors and can help psychosis but may cause sedation or worsen parkinsonism at higher doses. The study is looking for English-speaking veterans age 40 and older with Parkinson's and significant psychosis who are on stable PD medications and have a regular caregiver or "informed other" to attend visits, while excluding people with certain heart rhythm problems, recent high-dose antipsychotic use, dementia with Lewy bodies, or other serious medical issues.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 24 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 4 years.