Recruiting

Antipsychotic Medications

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05590637

Conditions

Parkinson's Disease Psychosis

Dementia With Lewy Bodies

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pimavanserin

Quetiapine

Study Details

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).

Conditions

Parkinson's Disease Psychosis

Dementia With Lewy Bodies

Study ID

NCT05590637

Start date

Apr 22, 2022

Status verified date

Sep, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: quetiapine

Elderly patients with dementia-related psychosis will be treated with quetiapine, an atypical antipsychotic indicated for the treeatment of: schizophrenia, bipolar I manic episodes and bipolar depressive episodes.

active comparator: pimavanserin

Elderly patients with dementia-related psychosis will be treated with pimavanserin, an atypical antipsychotic indicated for treatment of hallucinations and delusions associated with Parkinson's disease.

Interventions

Pimavanserin

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

Quetiapine

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

Primary outcome measure

  • Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Carolyn Paiz, BS

210-450-8830paizc@uthscsa.edu

Locations

University Health System

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Sarah Horn, MD

210-450-0500horns@uthscsa.edu

Carolyn Paiz, BS

210-450-8830paizc@uthscsa.edu

UT Health Science Center - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Carolyn Paiz

210-450-8830paizc@uthscsa.edu

Principal Investigator:

Sarah Horn, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • quetiapine
  • pimavanserin
  • psychosis
  • hallucinations
  • delusions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-09-09.