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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
Timeline
Screening 2 days
Treatment 4 months
Follow Up 2 weeks
Awards & highlights
C-SAPP Trial 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.Check my eligibility
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.See study design
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.
C-SAPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
C-SAPP Trial Timeline
Screening ~ 2 days0 visits
Treatment ~ 4 months6 visits
Follow Up ~ 2 weeks9 visits
Screening ~ 2 days
Treatment ~ 4 months
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Psychotic Disorders
Secondary outcome measures
CGI-I Parkinsonism
MDS-UPDRS III
SAPS-PD
+1 moreC-SAPP 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.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,304,826 Total Patients Enrolled
Daniel Weintraub, MDStudy ChairCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
4 Previous Clinical Trials
319 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I had DBS surgery less than 6 months ago or adjusted my stimulator last month.I have been diagnosed with Parkinson's Disease.I've been on a stable dose of an acetylcholinesterase inhibitor for at least 4 months.I might have an unusual form of Parkinson's or dementia with Lewy bodies.I am currently on medication that affects how my body processes drugs.I haven't taken any antipsychotic drugs except for low-dose quetiapine, which I stopped over a month ago.I am currently living in a nursing home or will be during the study.You understand what the study is about and agree to participate.I am not pregnant and willing to use contraception if I can have children.You are already participating in another study involving medication or treatment.You currently have severe mental health symptoms that require immediate treatment and prevent you from participating in the study.I have a history of irregular heartbeats that are not under control.You have served in the military.I am 18 years old or older.My caregiver is over 18, agrees to the study terms, and spends significant time with me daily.I am 40 years old or older.I have a history of long QT syndrome.I am taking medication that affects my heart's electrical cycle.My Parkinson's disease medication dose has been stable for at least a month.You are currently having suicidal thoughts or planning to harm yourself.I experience strong hallucinations or delusions.
Research Study Groups:
This trial has the following groups:- Group 1: Quetiapine
- Group 2: Pimavanserin 34mg
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 4 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open spots in this clinical research endeavor?
"Affirmative. Clinicaltrials.gov has the information that confirms this clinical trial, which opened on October 24th 2022 is actively enrolling participants. 358 patients are sought from 25 different medical locations."
Answered by AI
How is the medication Pimavanserin 34mg typically employed to assist patients?
"Pimavanserin 34mg is a popular treatment for Parkinson's disease Psychosis, as well as Major Depressive Disorder (MDD), Anxiety Disorders, and Acute Coryza."
Answered by AI
How many venues are offering participation in this research project?
"Currently, 25 clinical trial sites are recruiting patients for the study; prominent locations include San Francisco, Loma Linda and Palo Alto. To ease any transportation burdens that may come with enrollment, consider selecting a clinic near you."
Answered by AI
Are there any prior instances of administering Pimavanserin 34mg as part of a clinical trial?
"Originally trialled in 2014 at UT Southwestern Medical Centre, pimavanserin 34mg has since been tested 193 times. 18 of those trials are currently ongoing with the majority taking place within San Francisco, California."
Answered by AI
Has a similar trial been conducted before this one?
"Since 2014, Pimavanserin 34mg has undergone extensive clinical research. The first trial was conducted by Otsuka America Pharmaceutical and completed in the same year with 200 patients enrolled. Following this initial study, it received Phase 4 drug approval and is currently being tested across 189 cities over 33 countries in 18 live trials."
Answered by AI
What is the sample size of participants involved in this research endeavor?
"This clinical trial requires 358 suitable candidates to be enrolled. Locations in San Francisco, California and Loma Linda, Florida are both offering this medical research opportunity which adheres to the specified inclusion criteria."
Answered by AI
Is Pimavanserin 34mg a risk to the health of those who take it?
"Pimavanserin 34mg is confirmed to be safe, thus it was assigned a value of 3 on our scale. This determination was made due to the drug having already passed Phase 4 clinical trials and being approved for use."
Answered by AI
Who else is applying?
What site did they apply to?
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Philadelphia MultiService Center, Philadelphia, PA
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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