Comparing Pimavanserin and Quetiapine for Psychosis in Parkinson's and Lewy Body Dementia

This study is comparing two approved medications, pimavanserin and quetiapine, to see which one works better at reducing psychosis (hallucinations and delusions) in people with Parkinson's disease (PD) or dementia with Lewy bodies (DLB). These conditions are sometimes grouped as Lewy body disease (LBD). Researchers want to find out if one medication leads to a greater improvement in these symptoms when used in a regular clinical setting. You might be able to join if you are a patient at the neurology clinic at UT Health San Antonio, have psychosis due to PD or DLB, and need to start an antipsychotic medication. The study will measure improvements in psychosis over 6 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 94 participants. Participants will be randomly assigned to receive either pimavanserin or quetiapine.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to measure changes in their symptoms.

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NCT05590637

Comparing Antipsychotic Medications in LBD Over Time

Recruiting
PHASE4All AgesInterventionalTreatment
The University of Texas Health Science Center at San Antonio
~94 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:PimavanserinQuetiapine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
Measured over Baseline to 6 months
Parkinson's Disease Psychosis
Dementia With Lewy Bodies

NCT05590637

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University Health System

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • UT Health Science Center - San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Sarah Horn, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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Eligibility criteria

Inclusion

Patients seen in the neurology clinic at UT Health San Antonio
Diagnosed with psychosis due to PD or DLB
Requiring initiation of an antipsychotic medication
Clinical equipoise between quetiapine and pimavanserin must exist
The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin

Exclusion

Medical contraindication to either medication
Caregiver unavailable to complete NPI-Q
Currently taking an antipsychotic medication
Prescribing provider unwilling to manage either medication
  • Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)Baseline to 6 months

    Change in the Hallucinations + Delusions sub-score of the neuropsychiatric inventory questionnaire. Each NPI-Q item is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.