The University of Texas Health Science Center at San Antonio
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).
Parkinson's Disease Psychosis
Dementia With Lewy Bodies
Pimavanserin
Quetiapine
PHASE4
Psychosis (hallucinations and delusions) is a common problem in Parkinson's disease (PD) and dementia with Lewy bodies (DLB). PD is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. DLB is a similar disorder, though causes more severe cognitive and psychiatric problems. Psychosis is highly prevalent among people with PD and DLB, often manifesting as visual hallucinations or paranoid delusions. Up to 60% of people with PD will experience psychosis over the course of their disease. Psychosis is associated with increased mortality, caregiver burden, and poorer quality of life. More study is needed to determine the best way to treat psychosis in PD and DLB. Currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in PD and DLB. However, few comparison studies have been done and it is unclear if one medication is superior to the other. This will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to PD or DLB requiring initiation of a medication. Patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 94 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease |
| Actual Study Start Date : | 2022-04-22 |
| Estimated Primary Completion Date : | 2026-08 |
| Estimated Study Completion Date : | 2027-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University Health System
Saint Anthony, Texas, United States, 78229
RECRUITING
UT Health Science Center - San Antonio
Saint Anthony, Texas, United States, 78229