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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• 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 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

Locations
United States
Arizona
Southern Arizona VA Health Care System, Tucson, AZ
TERMINATED
Tucson
California
VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITING
Loma Linda
VA Palo Alto Health Care System, Palo Alto, CA
RECRUITING
Palo Alto
San Francisco VA Medical Center, San Francisco, CA
ACTIVE_NOT_RECRUITING
San Francisco
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
TERMINATED
West Los Angeles
Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
RECRUITING
Aurora
Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
ACTIVE_NOT_RECRUITING
Gainesville
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
ACTIVE_NOT_RECRUITING
Hines
Kentucky
Lexington VA Medical Center, Lexington, KY
TERMINATED
Lexington
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
ACTIVE_NOT_RECRUITING
Ann Arbor
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
ACTIVE_NOT_RECRUITING
St Louis
North Carolina
Asheville VA Medical Center, Asheville, NC
TERMINATED
Asheville
New Mexico
New Mexico VA Health Care System, Albuquerque, NM
TERMINATED
Albuquerque
New York
Syracuse VA Medical Center, Syracuse, NY
TERMINATED
Syracuse
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITING
Philadelphia
Philadelphia MultiService Center, Philadelphia, PA
RECRUITING
Philadelphia
Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
TERMINATED
Nashville
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
South Texas Health Care System, San Antonio, TX
TERMINATED
San Antonio
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
TERMINATED
Richmond
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
ACTIVE_NOT_RECRUITING
Seattle
Contact Information
Primary
Daniel Weintraub, MD
daniel.weintraub@va.gov
(215) 823-5800
Backup
John E Duda, MD
john.duda@va.gov
(215) 823-5934
Time Frame
Start Date: 2022-10-24
Estimated Completion Date: 2027-08-24
Participants
Target number of participants: 358
Treatments
Active_comparator: 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.
Active_comparator: 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
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov