Actively Recruiting
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Led by VA Office of Research and Development · Updated on 2025-08-28
358
Participants Needed
24
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran
- Age 40 years or older
- Diagnosis of Parkinson's Disease per UK Parkinson's Disease Society Brain Bank Criteria
- Psychosis with Neuropsychiatric Inventory hallucinations or delusions score 4 or greater
- Stable Parkinson's medications for at least 2 weeks
- If on acetylcholinesterase inhibitor, prescribed at least 3 months prior and stable for past month
- An informed other aged 18 or older with regular contact and able to attend all study visits
- English-speaking
You will not qualify if you...
- Psychosis symptoms too severe for clinical trial participation
- Treatment with quetiapine >50 mg/day or pimavanserin in past 3 months, or quetiapine 50 mg/day or other antipsychotic in past week
- Deep brain stimulation surgery within 3 months or recent stimulator adjustments
- History of psychotic disorders before Parkinson's disease
- Suspected atypical parkinsonian disorder or dementia with Lewy bodies
- Psychosis due to other toxic or metabolic causes
- History of long QT syndrome or certain cardiac arrhythmias
- Taking moderate or strong CYP3A4 inducers or inhibitors
- Use of drugs known to prolong QTc interval with risk of Torsades de Pointes
- Severe comorbid medical conditions preventing participation
- Previous intolerance to quetiapine or pimavanserin
- Severe cognitive impairment (MoCA score <5)
- Nursing home placement at screening or planned during study without approval
- Currently enrolled in another therapeutic or interventional study
- Pregnant or female of child-bearing potential unwilling to use contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723-0001
Terminated
2
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357-1000
Actively Recruiting
3
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
4
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Active, Not Recruiting
5
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Terminated
6
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Actively Recruiting
7
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Active, Not Recruiting
8
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Active, Not Recruiting
9
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States, 40502-2235
Terminated
10
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Active, Not Recruiting
11
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
12
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106-1621
Active, Not Recruiting
13
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
Terminated
14
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210-2716
Terminated
15
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, United States, 28805-2576
Terminated
16
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Actively Recruiting
18
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Actively Recruiting
19
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
20
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Terminated
21
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Actively Recruiting
22
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229-4404
Terminated
23
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001
Terminated
24
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Active, Not Recruiting
Research Team
D
Daniel Weintraub, MD
CONTACT
J
John E Duda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here