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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.