NCT05590637 Comparing Antipsychotic Medications in LBD Over Time
| NCT ID | NCT05590637 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Parkinson's Disease Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2022-04-22 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 94 participants in total. It began in 2022-04-22 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Medical contraindication to either medication * Caregiver unavailable to complete NPI-Q * Currently taking an antipsychotic medication * Prescribing provider unwilling to manage either medication
Contact & Investigator
Sarah Horn, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05590637 clinical trial?
This trial is open to participants of all sexes, studying Parkinson's Disease Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05590637 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05590637 currently recruiting?
Yes, NCT05590637 is actively recruiting participants. Contact the research team at paizc@uthscsa.edu for enrollment information.
Where is the NCT05590637 trial being conducted?
This trial is being conducted at San Antonio, United States, San Antonio, United States.
Who is sponsoring the NCT05590637 clinical trial?
NCT05590637 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Sarah Horn, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 94 participants.
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