Actively Recruiting

Phase 4
Age: 40Years +
All Genders
Healthy Volunteers
NCT04373317

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

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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