Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Recruiting Phase 4 Interventional Accepts healthy volunteers

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

ClinicalTrials.gov ID: NCT04373317

Public ClinicalTrials.gov record NCT04373317. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT04373317
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
358 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2022
Primary completion
Oct 23, 2027
Completion
Aug 23, 2028
Last update posted
Aug 18, 2026

2022 – 2028

United States locations

U.S. sites
24
U.S. states
19
U.S. cities
23
Facility City State ZIP Site status
Southern Arizona VA Health Care System, Tucson, AZ Tucson Arizona 85723-0001 Terminated
VA Loma Linda Healthcare System, Loma Linda, CA Loma Linda California 92357-1000 Recruiting
VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California 94304-1207 Recruiting
San Francisco VA Medical Center, San Francisco, CA San Francisco California 94121-1563 Terminated
VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California 90073-1003 Terminated
Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado 80045 Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida 32608-1135 Terminated
Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois 60141-3030 Terminated
Lexington VA Medical Center, Lexington, KY Lexington Kentucky 40502-2235 Terminated
VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan 48105-2303 Terminated
Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota 55417 Recruiting
St. Louis VA Medical Center John Cochran Division, St. Louis, MO St Louis Missouri 63106-1621 Terminated
New Mexico VA Health Care System, Albuquerque, NM Albuquerque New Mexico 87108-5153 Terminated
Syracuse VA Medical Center, Syracuse, NY Syracuse New York 13210-2716 Terminated
Asheville VA Medical Center, Asheville, NC Asheville North Carolina 28805-2576 Terminated
Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio 44106 Recruiting
VA Portland Health Care System, Portland, OR Portland Oregon 97239 Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania 19104-4551 Recruiting
Philadelphia MultiService Center, Philadelphia, PA Philadelphia Pennsylvania 19106 Recruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville Tennessee 37212-2637 Terminated
Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas 77030 Recruiting
South Texas Health Care System, San Antonio, TX San Antonio Texas 78229-4404 Terminated
Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond Virginia 23249-0001 Terminated
VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington 98108-1532 Terminated

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04373317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2026 · Synced Sep 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04373317 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →