Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
NCT ID: NCT04373317
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
358 participants
INTERVENTIONAL
2022-10-24
2027-08-24
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pimavanserin 34mg
Participants assigned to pimavanserin will receive 34mg (equivalent to 40 mg pimavanserin tartrate) daily without titration; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability.
Pimavanserin
Fixed-dose Pimavanserin - Pimavanserin is a new antipsychotic agent, and pure 5HT-2A inverse agonist, that was approved by the FDA recently (2016) for the treatment of PDP. It is the only FDA-approved medication for PDP, but is still not the first-line AP used in PD. All participants assigned to pimavanserin will receive the FDA-approved dose of 34 mg (equivalent to 40 mg pimavanserin tartrate) daily without titration up or down; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability (i.e., overall adverse event profile) and efficacy (i.e., improvement in severity of psychosis).
Quetiapine
Participants assigned to Quetiapine will be titrated from 25mg/day to a maximum of 200mg/day based on tolerability. During the 8-week treatment phase, there is a maximum of 6 weeks for titration.
Titration Schedule
Visit/call Quetiapine Dose (Flexible)Quetiapine Notes Baseline visit (Visit 00)25 mg IR QHSAll participants must be up-titrated to at least 50 mg/day at week 1 Week 1 call (Visit 01)50 mg XR QHS Up-titration Week 3 visit (Visit 03)100 mg XR QHS (requiring two 50-mg quetiapine XR capsules)Up- or down-titration as appropriate based on psychosis symptoms and tolerability Week 5 visit (Visit 05)150 mg quetiapine XR QHS Up- or down-titration as appropriate based on psychosis symptoms and tolerability Week 6 call (Visit 06)200 mg quetiapine XR QHS Up- or down-titration as appropriate based on psychosis symptoms and tolerability
Quetiapine
Flexible-dose Quetiapine - Quetiapine, which is a mixed serotonin and dopamine receptor antagonist, is by far the most commonly used AP for PDP. However, scientific evidence for the efficacy of quetiapine in PDP is almost non-existent as most of the studies were underpowered, had high drop-out rates, and possibly underdosed quetiapine. Quetiapine immediate and extended release will be titrated as shown:
Baseline visit Quetiapine: 25 mg IR QHS, All participants must be up-titrated to 50 mg/day
Week 1 call Quetiapine: 50 mg XR QHS, Up-titration to 50 mg
Week 3 visit Quetiapine: 100 mg XR QHS, Up-titration as appropriate
Week 5 visit Quetiapine: 150 mg XR QHS, Up- or down-titration as appropriate
Week 6 call Quetiapine: 200 mg XR QHS, Up- or down-titration as appropriate
Interventions
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Pimavanserin
Fixed-dose Pimavanserin - Pimavanserin is a new antipsychotic agent, and pure 5HT-2A inverse agonist, that was approved by the FDA recently (2016) for the treatment of PDP. It is the only FDA-approved medication for PDP, but is still not the first-line AP used in PD. All participants assigned to pimavanserin will receive the FDA-approved dose of 34 mg (equivalent to 40 mg pimavanserin tartrate) daily without titration up or down; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability (i.e., overall adverse event profile) and efficacy (i.e., improvement in severity of psychosis).
Quetiapine
Flexible-dose Quetiapine - Quetiapine, which is a mixed serotonin and dopamine receptor antagonist, is by far the most commonly used AP for PDP. However, scientific evidence for the efficacy of quetiapine in PDP is almost non-existent as most of the studies were underpowered, had high drop-out rates, and possibly underdosed quetiapine. Quetiapine immediate and extended release will be titrated as shown:
Baseline visit Quetiapine: 25 mg IR QHS, All participants must be up-titrated to 50 mg/day
Week 1 call Quetiapine: 50 mg XR QHS, Up-titration to 50 mg
Week 3 visit Quetiapine: 100 mg XR QHS, Up-titration as appropriate
Week 5 visit Quetiapine: 150 mg XR QHS, Up- or down-titration as appropriate
Week 6 call Quetiapine: 200 mg XR QHS, Up- or down-titration as appropriate
Eligibility Criteria
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Inclusion Criteria
* Age 40 years or older
* Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
* Psychosis \[with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater\]
* Stable dose of PD medications for at least 2 weeks
* If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month
* Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular contact with the patient (on average at least 4 days per week and at least 2 hours per day, or at least 3 days per week and at least 4 hours per day, that is with patient) via in-person, video, or telephone
* English-speaking
INFORMED OTHER
* Age 18 years or older
* Must have regular contact with the patient (on average at least 4 days per week, and at least 2 hours per day, or at least 3 days per week and at least 4 hours pr day, that is with patient) via in-person, video, or telephone
* Agree to attend all study visits
* Be able to provide informed consent
* English-speaking
Exclusion Criteria
* Treatment with quetiapine \>50 mg/day or pimavanserin in the past 3 months, or quetiapine 50 mg/day or another antipsychotic in the past week prior to study randomization
* Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks
* History of a psychotic disorder prior to PD, including bipolar disorder, schizophrenia, schizoaffective disorder, and major depressive disorder with psychotic features, if it is thought to be the cause of the current psychosis symptoms
* Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
* Psychosis secondary to other toxic or metabolic disorder
* History of long QT syndrome
* Documented chart evidence indicating persistent hypoglycemia, hypokalemia, hypomagnesemia that would put patient at increased risk for QTc prolongation.
* History of ventricular arrhythmias, except when treated with an implantable cardioverter defibrillator (ICD) or pacemaker, or untreated or unstable atrial fibrillation/flutter
* Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors
* Concomitant use of drugs that prolong the QTc interval with a known risk of Torsades de Pointes
* Comorbid medical condition determined too severe by Site Investigator to allow participation in clinical trial
* Failure to tolerate quetiapine or pimavanserin previously
* Severe cognitive impairment (MoCA score \<5)
* Nursing home placement at screening or planned placement during the study, unless approved by study Co-Chairs. Approval will depend upon nursing facility agreement to receive, return, and administer medications or allow participant to self-administer study medications; appropriate IO availability; and transportation availability for study visits.
* Currently enrolled in another therapeutic or interventional study
* Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception
40 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Daniel Weintraub, MD
Role: STUDY_CHAIR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Locations
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Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015
Identifier Type: -
Identifier Source: org_study_id
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