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Antipsychotic

Pimavanserin vs. Quetiapine for Psychosis in Parkinson's Disease (C-SAPP Trial)

Phase 4

Recruiting

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40 years or older

Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria

Must not have

Deep brain stimulation (DBS) surgery occurring within 6 months prior or has had stimulator adjustments in the previous month

Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)

Timeline

Screening 2 days

Treatment 4 months

Follow Up 2 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the safety and effectiveness of Quetiapine and Pimavanserin in Veterans with Parkinson's disease psychosis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include changes in mood or behavior, dizziness or lightheadedness due to low blood pressure, nausea or digestive issues, abnormal heart rhythms (QT prolongation), sleepiness during the day and trouble sleeping at night.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have been diagnosed with Parkinson's Disease.

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I experience strong hallucinations or delusions.

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My caregiver is over 18, agrees to the study terms, and spends significant time with me daily.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had DBS surgery less than 6 months ago or adjusted my stimulator last month.

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I might have an unusual form of Parkinson's or dementia with Lewy bodies.

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My psychosis is due to a toxic or metabolic disorder.

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I have a history of long QT syndrome.

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I have a history of irregular heartbeats that are not under control.

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I am currently on medication that affects how my body processes drugs.

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I am taking medication that affects my heart's electrical cycle.

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I couldn't tolerate quetiapine or pimavanserin.

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I am currently living in a nursing home or will be during the study.

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I am not pregnant and willing to use contraception if I can have children.

Timeline

Screening ~ 2 days0 visits

Treatment ~ 4 months6 visits

Follow Up ~ 2 weeks9 visits

Screening ~ 2 days

Treatment ~ 4 months

Follow Up ~2 weeks

This trial's timeline: 2 days for screening, 4 months for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Psychotic Disorders

Secondary study objectives

CGI-I Parkinsonism

MDS-UPDRS III

SAPS-PD

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: QuetiapineActive Control1 Intervention

Quetiapine extended release will be titrated as shown in the following table. 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 QHSUp-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 QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability Week 6 call (Visit 06)200 mg quetiapine XR QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability

Group II: Pimavanserin 34mgActive Control1 Intervention

All participants assigned to pimavanserin will receive the FDA-approved dose of 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.

0 / 15Eligibility criteria met