358 Participants Needed

Pimavanserin vs. Quetiapine for Psychosis in Parkinson's Disease

(C-SAPP Trial)

Recruiting at 17 trial locations
DW
JE
Overseen ByJohn E Duda, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not been treated with an antipsychotic, including pimavanserin, in the past year, except for quetiapine at less than 50 mg/day, which must be stopped at least 1 month before joining the study. If you are taking medications that affect the heart's rhythm or certain other drugs, you may need to stop those as well.

Is Pimavanserin safe for treating psychosis in Parkinson's disease?

Pimavanserin has been associated with an increased risk of death in some reports, but when compared to other treatments for Parkinson's disease psychosis, it did not show an excess of death reports. It's important to discuss the risks and benefits with your doctor.12345

How is the drug pimavanserin different from other drugs for Parkinson's disease psychosis?

Pimavanserin is unique because it is the only FDA-approved drug specifically for treating hallucinations and delusions in Parkinson's disease psychosis, unlike quetiapine, which is used off-label. Pimavanserin works by targeting serotonin receptors, which helps manage psychosis without worsening Parkinson's motor symptoms.24678

What data supports the effectiveness of the drug quetiapine for treating psychosis in Parkinson's disease?

Research shows that quetiapine can effectively reduce psychotic symptoms like hallucinations and delusions in patients with Parkinson's disease, without worsening their motor symptoms. It is well-tolerated and can also improve cognitive functions, making it a viable option for managing psychosis in these patients.4891011

Who Is on the Research Team?

DW

Daniel Weintraub, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

This trial is for Veterans with Parkinson's Disease who are experiencing psychosis, such as hallucinations or delusions. Participants must be English-speaking adults over 40 years old, have regular contact with a caregiver, and not live in a nursing home. They can't have used certain antipsychotics recently, have heart rhythm problems, severe dementia or other disqualifying conditions.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease.
I've been on a stable dose of an acetylcholinesterase inhibitor for at least 4 months.
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)
See 9 more

Exclusion Criteria

You had a mental health condition like schizophrenia or bipolar disorder before Parkinson's disease.
My psychosis is due to a toxic or metabolic disorder.
I couldn't tolerate quetiapine or pimavanserin.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Quetiapine or Pimavanserin for Parkinson's Disease Psychosis. Quetiapine is titrated over 6 weeks, while Pimavanserin is administered at a fixed dose with sham titration.

8 weeks
4 visits (in-person) at baseline, 3 weeks, 5 weeks, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pimavanserin
  • Quetiapine
Trial Overview The study compares the safety and effectiveness of two antipsychotic drugs: Quetiapine (commonly used but not FDA-approved for PD psychosis) versus Pimavanserin (newer and FDA-approved specifically for PD psychosis). The goal is to determine which drug works best for treating psychosis in Parkinson's patients.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: QuetiapineActive Control1 Intervention
Group II: Pimavanserin 34mgActive Control1 Intervention

Pimavanserin is already approved in United States for the following indications:

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Approved in United States as Nuplazid for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

In a study of 27 patients with Parkinson's disease and recent-onset psychosis, both quetiapine and clozapine were found to be effective treatments, with no worsening of parkinsonism observed during the 22-week treatment period.
Clozapine showed a greater ability to reduce delusions and had a trend towards better control of hallucinations compared to quetiapine, but it also posed a risk of leukopenia, highlighting the need for careful monitoring.
Rater-blinded, prospective comparison: quetiapine versus clozapine for Parkinson's disease psychosis.Merims, D., Balas, M., Peretz, C., et al.[2022]
In a study of 10 patients with Parkinson's disease experiencing psychosis due to antiparkinsonian drugs, quetiapine effectively eliminated psychotic symptoms in 9 out of 10 patients.
Quetiapine was associated with no significant worsening of parkinsonism, highlighting its safety and efficacy as a treatment for psychosis in this population.
[Effect of quetiapine fumarate on drug-induced psychosis in patients with Parkinson's disease].Kohmoto, J., Kihira, T., Miwa, H., et al.[2015]
In three case histories of Parkinson's disease patients who had to stop clozapine, switching to quetiapine resulted in behavioral improvements without significantly worsening motor symptoms, indicating its potential as a safer alternative.
Quetiapine was well tolerated at doses ranging from 12.5 to 150 mg/day, suggesting it may effectively manage psychosis and agitation in Parkinson's disease patients while minimizing the risk of exacerbating parkinsonism.
Quetiapine as an alternative to clozapine in the treatment of dopamimetic psychosis in patients with Parkinson's disease.Menza, MM., Palermo, B., Mark, M.[2019]

Citations

Rater-blinded, prospective comparison: quetiapine versus clozapine for Parkinson's disease psychosis. [2022]
[Effect of quetiapine fumarate on drug-induced psychosis in patients with Parkinson's disease]. [2015]
Quetiapine as an alternative to clozapine in the treatment of dopamimetic psychosis in patients with Parkinson's disease. [2019]
Efficacy of quetiapine in Parkinson's patients with psychosis. [2019]
Quetiapine improves psychotic symptoms and cognition in Parkinson's disease. [2015]
Pimavanserin (Nuplazidโ„ข) for the treatment of Parkinson disease psychosis: A review of the literature. [2022]
Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries. [2023]
Pimavanserin: First Global Approval. [2022]
Comparative pharmacovigilance assessment of mortality with pimavanserin in Parkinson disease-related psychosis. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Guidance for switching from off-label antipsychotics to pimavanserin for Parkinson's disease psychosis: an expert consensus. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Management of Parkinson's Disease Psychosis. [2022]
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