RECRUITING

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)

Quick Facts

Study Start:2022-10-24
Study Completion:2027-08-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04373317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran
  2. * Age 40 years or older
  3. * Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
  4. * Psychosis \[with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater\]
  5. * Stable dose of PD medications for at least 2 weeks
  6. * If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month
  7. * 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
  8. * English-speaking
  9. * Age 18 years or older
  10. * 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
  11. * Agree to attend all study visits
  12. * Be able to provide informed consent
  13. * English-speaking
  1. * Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
  2. * 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
  3. * Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks
  4. * 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
  5. * Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
  6. * Psychosis secondary to other toxic or metabolic disorder
  7. * History of long QT syndrome
  8. * Documented chart evidence indicating persistent hypoglycemia, hypokalemia, hypomagnesemia that would put patient at increased risk for QTc prolongation.
  9. * History of ventricular arrhythmias, except when treated with an implantable cardioverter defibrillator (ICD) or pacemaker, or untreated or unstable atrial fibrillation/flutter
  10. * Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors
  11. * Concomitant use of drugs that prolong the QTc interval with a known risk of Torsades de Pointes
  12. * Comorbid medical condition determined too severe by Site Investigator to allow participation in clinical trial
  13. * Failure to tolerate quetiapine or pimavanserin previously
  14. * Severe cognitive impairment (MoCA score \<5)
  15. * 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.
  16. * Currently enrolled in another therapeutic or interventional study
  17. * Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception

Contacts and Locations

Study Contact

Daniel Weintraub, MD
CONTACT
(215) 823-5800
daniel.weintraub@va.gov
John E Duda, MD
CONTACT
(215) 823-5934
john.duda@va.gov

Principal Investigator

Daniel Weintraub, MD
STUDY_CHAIR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Locations (Sites)

Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723-0001
United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357-1000
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, 40502-2235
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106-1621
United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
United States
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
United States
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, 28805-2576
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
United States
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19106
United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Daniel Weintraub, MD, STUDY_CHAIR, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-24
Study Completion Date2027-08-24

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2027-08-24

Terms related to this study

Keywords Provided by Researchers

  • Pimavanserin
  • Quetiapine

Additional Relevant MeSH Terms

  • Parkinson's Disease Psychosis