Compare pimavanserin and quetiapine effectiveness
- Trial ID
- NCT05590637
- Official Title
- A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
- Goal
- Compare pimavanserin and quetiapine effectiveness
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Study Type
- INTERVENTIONAL
- Enrollment
- 94 participants
- Conditions
- Parkinson's Disease Psychosis, Dementia With Lewy Bodies
- Interventions
- Pimavanserin, Quetiapine
Plain-Language Summary
They're comparing two antipsychotics to see which better controls hallucinations and delusions in people with Parkinson's disease psychosis or dementia with Lewy bodies, while keeping an eye on safety and effects on movement. One drug, pimavanserin, blocks serotonin 5‑HT2A receptors and treats psychosis without blocking dopamine receptors, so it is less likely to worsen Parkinsonian movement or interfere with levodopa; the other, quetiapine, is an atypical antipsychotic that blocks dopamine and serotonin receptors, which can calm psychosis but may cause sedation or motor side effects. The trial enrolls neurology clinic patients at UT Health San Antonio who have PD psychosis or DLB and need to start an antipsychotic, are not already on one, have a caregiver able to complete symptom questionnaires, and have a prescriber comfortable prescribing and managing either medication.
Locations
- University Health System, San Antonio, Texas, United States
- UT Health Science Center - San Antonio, San Antonio, Texas, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Pimavanserin. They're comparing two antipsychotics to see which better controls hallucinations and delusions in people with Parkinson's disease psychosis or dementia with Lewy bodies, while keeping an eye on safety and effects on movement. One drug, pimavanserin, blocks serotonin 5‑HT2A receptors and treats psychosis without blocking dopamine receptors, so it is less likely to worsen Parkinsonian movement or interfere with levodopa; the other, quetiapine, is an atypical antipsychotic that blocks dopamine and serotonin receptors, which can calm psychosis but may cause sedation or motor side effects. The trial enrolls neurology clinic patients at UT Health San Antonio who have PD psychosis or DLB and need to start an antipsychotic, are not already on one, have a caregiver able to complete symptom questionnaires, and have a prescriber comfortable prescribing and managing either medication.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 4 years and 3 months.