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Clozapine Therapy Sample Collection - Method Comparison Study

NCT05422131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2023-05-18

No results posted yet for this study

Summary

The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.

Conditions

  • Patients Prescribed Clozapine

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • University of Maryland, Baltimore

    collaborator OTHER

  • Saladax Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Christenson · University of Maryland

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-12
Primary Completion
2023-01-25
Completion
2023-05-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422131 on ClinicalTrials.gov