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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
University Health System
San Antonio, Texas, United States
RECRUITINGUT Health Science Center - San Antonio
San Antonio, Texas, United States
RECRUITINGNeuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
Change in the Hallucinations + Delusions sub-score of the neuropsychiatric inventory questionnaire. Each NPI-Q item is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
Change in the total neuropsychiatric inventory questionnaire score, which includes 12 items, each scored from 0-8 with a higher score indicating more severe symptoms.
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
Change in the neuropsychiatric inventory questionnaire item for anxiety, scored from 0-8 with a higher score indicating more severe anxiety.
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
Change in the neuropsychiatric inventory questionnaire for agitation, scored from 0-8 with a higher score indicating more severe agitation.
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
Change in the neuropsychiatric inventory questionnaire for sleep disturbance, scored from 0-8 with a higher score indicating more severe sleep disturbances.
Time frame: Baseline to 6 months
Mortality
Number of subjects who survived until the 6 month study assessment visit
Time frame: 6 months
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Time to discontinuation of per-protocol medication
Will examine whether participants continued the chosen medication until study completion or if they either discontinued the study medication or added the other study medication.
Time frame: Baseline to 6 months
MDS-UPDRS part 3
Unified Parkinson's Disease Rating Scale, motor score. The motor examination scale consists of 33 items graded 0-4 points with an overall possible score of 0-132 points. A higher score indicates a higher burden of motor symptoms.
Time frame: Baseline to 6 months
CGIC, PGIC, CGI-C:CVR
Clinician, patient, and caregiver global impressions of change. Each is a single item assessment rated from 1 (very much improved) to 7 (very much worse). A higher score indicates worsening symptoms.
Time frame: Baseline to 6 months