Clinical trial NCT04373317: Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Official title: CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Parkinson's Disease Psychosis
Keywords: Pimavanserin
Quetiapine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-04
Enrollment: 358
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two active treatments will be administered in this RCT, with 1:1 treatment assignment to either quetiapine or pimavanserin. Both active treatments are FDA-approved antipsychotics.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Veteran
* 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 1 month
* 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 in-person contact with the patient (at least 5 days per week, and at least 4 hours per day that is spent with patient)
* English-speaking

INFORMED OTHER

* Age 18 years or older
* Must have regular in-person contact with the patient (on average at least 5 days per week, and at least 4 hours per day that is spent with patient)
* Agree to attend all study visits
* Be able to provide informed consent
* English-speaking

Exclusion Criteria:

* Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
* Treatment with an antipsychotic, including pimavanserin in the past year, except quetiapine \<50 mg/day which has been discontinued for at least 1 month prior to study randomization
* Deep brain stimulation (DBS) surgery occurring within 6 months prior or has had stimulator adjustments in the previous month
* History of a psychotic disorder prior to PD, including schizophrenia and bipolar disorder
* Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
* Psychosis secondary to other toxic or metabolic disorder
* History of long QT syndrome
* Prolonged QTc \[\>450ms in men, \>470ms in women\] at screening
* History of ventricular arrhythmias, 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 prolongs the QTc interval
* Comorbid medical condition determined too severe by SI to allow participation in clinical trial
* Failure to tolerate quetiapine or pimavanserin previously
* Moderate to severe PD dementia (MoCA score \<13)
* Currently enrolled in another therapeutic or interventional study
* Nursing home placement at screening or planned placement during the study
* Active suicidality
* Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception

Primary outcomes:
measure: CGI-I Psychosis
timeFrame: 8 Weeks
Secondary outcomes:
measure: SAPS-PD
timeFrame: 8 Weeks
measure: MDS-UPDRS III
timeFrame: 8 Weeks
measure: Zarit Caregiver Burden Scale
timeFrame: 8 Weeks
measure: CGI-I Parkinsonism
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Tucson, AZ
state: Arizona
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System, Loma Linda, CA
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Lexington
country: United States
facility: Lexington VA Medical Center, Lexington, KY
state: Kentucky
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
city: Asheville
country: United States
facility: Asheville VA Medical Center, Asheville, NC
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia MultiService Center, Philadelphia, PA
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Daniel Weintraub, MD
role: STUDY_CHAIR
References: