Clozapine Therapy Sample Collection - Method Comparison Study
NCT ID: NCT05422131
Last Updated: 2023-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
153 participants
OBSERVATIONAL
2022-11-12
2023-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients Prescribed Clozapine
MyCare Insite Clozapine Test
The MyCare Insite Clozapine Test is a 2 reagent system designed to evaluate the level of antipsychotic drug clozapine in a patients blood using the near patient device the MyCare Insite Analyser.
Interventions
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MyCare Insite Clozapine Test
The MyCare Insite Clozapine Test is a 2 reagent system designed to evaluate the level of antipsychotic drug clozapine in a patients blood using the near patient device the MyCare Insite Analyser.
Eligibility Criteria
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Inclusion Criteria
1. Female or male subjects 21 years of age or older;
2. Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
3. Capable of understanding and complying with parameters as outlined in the protocol;
4. Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures.
Exclusion Criteria
21 Years
ALL
Yes
Sponsors
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Northwell Health
OTHER
University of Maryland, Baltimore
OTHER
Saladax Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Christenson
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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Saladax Biomedical, Inc.
Bethlehem, Pennsylvania, United States
Countries
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Other Identifiers
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SBI-CLZ-002
Identifier Type: -
Identifier Source: org_study_id
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