Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
NCT04373317 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Quetiapine
- DRUG Pimavanserin
Study Locations (20)
California
- VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
- San Francisco VA Medical Center, San Francisco, CA — San Francisco
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia
- Philadelphia MultiService Center, Philadelphia, PA — Philadelphia
Arizona
- Southern Arizona VA Health Care System, Tucson, AZ — Tucson
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Kentucky
- Lexington VA Medical Center, Lexington, KY — Lexington
Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2027-08-24 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04373317
The ClinicalTrials.gov registry entry for NCT04373317 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson's Disease Psychosis appearing as the primary indexed condition, and to 2 interventions — of which Quetiapine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04373317 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Pennsylvania, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04373317 about?
NCT04373317 is a clinical study titled "Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis". 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, mem...
What is the current status of trial NCT04373317?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 358 participants. The study started on 2022-10-24. Estimated completion is 2027-08-24.
What conditions does trial NCT04373317 study?
This clinical trial studies the following conditions: Parkinson's Disease Psychosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04373317?
The interventions under investigation include: Quetiapine (DRUG), Pimavanserin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04373317?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04373317 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.