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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 November 2024 |
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Main ID: |
NCT05590637 |
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Date of registration:
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18/10/2022 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing Antipsychotic Medications in LBD Over Time
CAMELOT |
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Scientific title:
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A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease |
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Date of first enrolment:
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April 22, 2022 |
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Target sample size:
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94 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05590637 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Carolyn Paiz, BS |
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Address:
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Telephone:
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210-450-8830 |
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Email:
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paizc@uthscsa.edu |
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Affiliation:
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Name:
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Sarah Horn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Health Science Center San Antonio |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dementia With Lewy Bodies
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Parkinson's Disease Psychosis
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Intervention(s)
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Drug: Pimavanserin
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Drug: Quetiapine
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Primary Outcome(s)
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Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
[Time Frame: Baseline to 6 months]
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Secondary Outcome(s)
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MDS-UPDRS part 3
[Time Frame: Baseline to 6 months]
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Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
[Time Frame: Baseline to 6 months]
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Time to discontinuation of per-protocol medication
[Time Frame: Baseline to 6 months]
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CGIC, PGIC, CGI-C:CVR
[Time Frame: Baseline to 6 months]
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Mortality
[Time Frame: 6 months]
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Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
[Time Frame: Baseline to 6 months]
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Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
[Time Frame: Baseline to 6 months]
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Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
[Time Frame: Baseline to 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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