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OpenTrials
Completed

NCT Number: NCT05422131

Clozapine Therapy Sample Collection - Method Comparison Study

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.

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Key information

Conditions

Patients Prescribed Clozapine

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saladax Biomedical, Inc.

Bethlehem, Pennsylvania, 18015, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study subjects must meet all the following criteria to be eligible for enrollment into the study:
  • Female or male subjects 21 years of age or older;
  • Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
  • Capable of understanding and complying with parameters as outlined in the protocol;
  • 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

  • 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.

Treatment and study plan

MyCare Insite Clozapine Test

Device

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.

Primary outcomes

  1. Sample Analysis - Method Comparision

    Time frame: October, 2022

    Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS

Sponsors and collaborators

Lead sponsor

Saladax Biomedical, Inc.

Industry

Collaborators

  • Northwell Health
  • University of Maryland, Baltimore

Registry information

Official study title

Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.