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Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Sponsor: VA Office of Research and Development
Summary
Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time. Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety. The purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis. Enrollment is open to Veterans nationwide, see your VA provider about the possibility of being referred to one of the study's Hub sites. This can be done through contact from your provider to the study's NSC (Tamara Boney at 267-303-9829).
Official title: CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
358
Start Date
2022-10-24
Completion Date
2027-08-24
Last Updated
2025-08-28
Healthy Volunteers
Yes
Conditions
Interventions
Pimavanserin
Fixed-dose Pimavanserin - Pimavanserin is a new antipsychotic agent, and pure 5HT-2A inverse agonist, that was approved by the FDA recently (2016) for the treatment of PDP. It is the only FDA-approved medication for PDP, but is still not the first-line AP used in PD. All participants assigned to pimavanserin will receive the FDA-approved dose of 34 mg (equivalent to 40 mg pimavanserin tartrate) daily without titration up or down; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability (i.e., overall adverse event profile) and efficacy (i.e., improvement in severity of psychosis).
Quetiapine
Flexible-dose Quetiapine - Quetiapine, which is a mixed serotonin and dopamine receptor antagonist, is by far the most commonly used AP for PDP. However, scientific evidence for the efficacy of quetiapine in PDP is almost non-existent as most of the studies were underpowered, had high drop-out rates, and possibly underdosed quetiapine. Quetiapine immediate and extended release will be titrated as shown: Baseline visit Quetiapine: 25 mg IR QHS, All participants must be up-titrated to 50 mg/day Week 1 call Quetiapine: 50 mg XR QHS, Up-titration to 50 mg Week 3 visit Quetiapine: 100 mg XR QHS, Up-titration as appropriate Week 5 visit Quetiapine: 150 mg XR QHS, Up- or down-titration as appropriate Week 6 call Quetiapine: 200 mg XR QHS, Up- or down-titration as appropriate
Locations (24)
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
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States