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RECRUITING
NCT04373317
PHASE4

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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