Clozapine Therapy Sample Collection - Method Comparison Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05422131

Enrollment

153

Registered

2022-06-16

Start date

2022-11-12

Completion date

2023-05-16

Last updated

2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Prescribed Clozapine

Brief 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.

Interventions

DEVICEMyCare 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Study subjects must meet all the following criteria to be eligible for enrollment into the study: 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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Sample Analysis - Method Comparision	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026