Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
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.
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
Conditions
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
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04373317 live on ClinicalTrials.gov.