Recruiting · registry statusComparing medicines for hallucinations and other symptoms affecting reality
Researchers compare pimavanserin and quetiapine for Parkinson’s-related psychosis, which can involve seeing things or holding beliefs that do not match reality.
Testing a treatment or activity · Study reference: NCT04373317
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Follow this study
Looking for volunteers
- Start (reported actual date)
- 2022-10-24
- Main measurements finished (planned)
- 2027-10-24
- Study finished (planned)
- 2028-08-24
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Age 40 years and over · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* Veteran
* 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:
* Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
* 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
Full study name & original research details
Official study title
CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
Short title used by the registry
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Original 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).
Further description from the registry
CSP #2015 - C-SAPP is a randomized, intent-to-treat, double-blind, two-arm, parallel design, multicenter comparator study. A total of up to approximately 24 Department of Veterans Affairs Medical Centers (VAMCs) will be invited to participate in the study. Veterans age 40 years and older with PD and symptoms of psychosis will be pre-screened for enrollment (consent) using established inclusion/exclusion criteria. Enrolled participants meeting eligibility will be randomized in a blinded fashion to one of two arms (fixed-dose pimavanserin or flexible-dose quetiapine), stratified by cognitive impairment \[per the Montreal Cognitive Assessment (MoCA)\]. Assessments will be collected at multiple time points - baseline, week 3, week 5, and at week 8 after randomization. Assessments of psychosis (CGI-I psychosis), PDP symptoms (SAPS-PD), and nighttime sleep/daytime sleepiness \[per Scales for Outcomes in PD-Sleep Scale nighttime subscale (SCOPA-S NS)/Epworth Sleepiness Scale (ESS)\] will be completed at each in-person visit, while caregiver burden (ZBI), functioning and well-being \[per the Parkinson's Disease Questionnaire-8 (PDQ-8)\] will be assessed at baseline and treatment visits of weeks 5 and 8, parkinsonism (CGI-I parkinsonism) and motor abilities (MDS-UPDRS III) at baseline and week 8, and cognition (MoCA) at screening and week 8. Additional contact by phone/video will occur at weeks 1 and 6. PD medications and side-effects will also be collected. SAEs, and AEs using the Treatment Emergent Symptom Scale (TESS) for guidance, will be continuously monitored at each participant contact (in-person and phone/video). A quality by design (QbD) approach was utilized focusing on its key principles to help prospectively identify important errors that could jeopardize the reliability of the data and safety of study participants.
Conditions reported: Parkinson's Disease Psychosis
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Pimavanserin; Quetiapine
- Phases
- PHASE4
- Sponsor
- VA Office of Research and Development
- Start date reported by registry
- 2022-10-24 (actual)
Registry updated: 2026-08-19 · Status last verified by the registry submitter: 2026-08
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Daniel Weintraub, MD · (215) 823-5800 · daniel.weintraub@va.gov
John E Duda, MD · (215) 823-5934 · john.duda@va.gov
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States
Stopped earlyVA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States
RecruitingDorothee Cole, MD · 909-825-7084 · Dorothee.Cole@va.gov
Sonia Read · 9098257084 · Sonia.Read@va.gov
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
RecruitingShannon Kilgore, MD · 650-858-3999 · Shannon.Kilgore@va.gov
Cheyenne Murphy · 6504935000 · Cheyenne.Murphy@va.gov
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
Stopped earlyVA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Stopped earlyRocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
RecruitingJeanne Feuerstein, MD · 720-723-6205 · Jeanne.Feuerstein@va.gov
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Stopped earlyEdward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Stopped earlyLexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States
Stopped earlyVA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Stopped earlyMinneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
RecruitingJames Ashe, MD · 612-725-2000 · James.Ashe@va.gov
Molly Carson · 6127252000 · Molly.Carson@va.gov
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States
Stopped earlyNew Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States
Stopped earlySyracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States
Stopped earlyAsheville VA Medical Center, Asheville, NC
Asheville, North Carolina, United States
Stopped earlyLouis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
RecruitingPeijun Chen · 216-791-3800 · Peijun.Chen@va.gov
Aasef Shaikh · 2167913800 · Aasef.Shaikh@va.gov
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
RecruitingJoel Mack, MD · 503-220-8262 · Joel.Mack@va.gov
Michael Tanaka · 5032208262 · Michael.Tanaka2@va.gov
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
RecruitingDaniel Weintraub, MD · (215) 823-5800 · daniel.weintraub@va.gov
Daniel Weintraub, MD
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
RecruitingJames Morley, MD · 215-823-5934 · James.Morley@va.gov
Philip Danquah · Philip.Danquah@va.gov
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
Stopped earlyMichael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
RecruitingAliya Sarwar, MD · 713-794-7841 · Aliya.Sarwar@va.gov
Priscilla Bigner · 7137947939 · Priscilla.Bigner@va.gov
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
Stopped earlyHunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
Stopped earlyVA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Stopped earlyFacility not reported
United States
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.