RecruitingPhase 4

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares pimavanserin and quetiapine to learn which works better and is safer for Parkinson’s psychosis. It is open to Veterans with Parkinson’s disease who see or hear things that are not real or believe things that are not true.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be a Veteran who speaks English.
  • You must have Parkinson’s disease diagnosed using the study’s rules.
  • You must have hallucinations or false beliefs with a score of at least 4 on the study’s symptom rating scale.
  • Your Parkinson’s medicine doses must have stayed the same for at least 2 weeks.
  • If you take an acetylcholinesterase inhibitor, a type of memory medicine, you must have started it at least 3 months ago. The medicine and dose must have stayed the same for the past month.
  • You must have a support person who is at least 18, speaks English, agrees to take part, and attends all study visits.
  • Your support person must have contact with you in person, by video, or by phone: at least 4 days a week for 2 hours a day, or 3 days a week for 4 hours a day.

Who can't join

  • Your psychosis needs urgent care, or another health problem is too severe for you to safely join.
  • You took pimavanserin or more than 50 mg of quetiapine daily in the past 3 months; took 50 mg of quetiapine daily or another antipsychotic in the past week; or could not tolerate either study drug before.
  • You had deep brain stimulation surgery in the past 3 months, or changes to the brain stimulator’s settings in the past 2 weeks.
  • Your symptoms may come from a mental illness that started before Parkinson’s, another Parkinson-like illness, Lewy body dementia, or a problem caused by toxins or the body’s chemical balance.
  • You have certain heart rhythm problems, long QT syndrome (a problem with the heart’s electrical timing), or ongoing low blood sugar, potassium, or magnesium that raises heart rhythm risk. Some treated rhythm problems may be allowed.
  • You take certain medicines that change how the body breaks down drugs or that raise the risk of a dangerous heart rhythm.
  • You have severe memory or thinking problems, with a MoCA test score below 5; live in or plan to enter a nursing home without special study approval; or are in another treatment or intervention study.
  • You are pregnant, or you could become pregnant and will not use reliable birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (24)

AZ

CA

CO

FL

IL

KY

MI

MN

MO

NC

NM

NY

OH

OR

PA

TN

TX

VA

WA

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, WA 98108-1532More trials in Seattle