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NCT05590637RecruitingPhase 4

Comparing Antipsychotic Medications in LBD Over Time

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
94 (estimated)
First submitted
18 Oct 2022
Start date
22 Apr 2022
Primary completion date
Aug 2026
Lead sponsor
The University of Texas Health Science Center at San Antonio
NCT number
NCT05590637

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 94
  • From 22 Apr 2022 to the primary completion date, Aug 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medical contraindication to either medication
  • Currently taking an antipsychotic medication
  • Prescribing provider unwilling to manage either medication

Other

  • Caregiver unavailable to complete NPI-Q

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UT Health Science Center San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
University Health System
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.