Parkinson's Disease Psychosis study: Pimavanserin vs Quetiapine
Official title Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
ClinicalTrials.gov ID: NCT04373317
What this study is testing
What is Pimavanserin?
This is an investigational medicine being studied to treat hallucinations and delusions in people with Parkinson's disease. It is designed to block specific serotonin receptors in the brain to help reduce psychotic symptoms.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether Pimavanserin or Quetiapine works better. It also checks how safe each medicine is.
- Who it's for
- You may be able to join if you are a Veteran with Parkinson's disease and see or hear things that are not real.
- What's involved
- You would take one of two medicines. You would visit the study team for check-ups and tests.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
- Psychosis secondary to other toxic or metabolic disorder
See the full eligibility 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...
- 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...
- Agree to attend all study visits
- Be able to provide informed consent
- English-speaking
- 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...
- 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.
- Currently enrolled in another therapeutic or treatment study
- Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception
The study team makes the final eligibility decision.
Where it is enrolling
- Loma Linda, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Minneapolis, Minnesota, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Loma Linda, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Minneapolis, Minnesota, United States; Cleveland, Ohio, United States; Portland, Oregon, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.