Clozapine Therapy Sample Collection - Method Comparison Study

NCT05422131 | Completed DMC FDA Device

• 1 other identifier: SBI-CLZ-002
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Prescribed Clozapine

Outcome Measures

Primary Outcomes (1)

• Sample Analysis - Method Comparision

  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

  October, 2022

Study Arms (1)

Patients Prescribed Clozapine

Device: MyCare Insite Clozapine Test

Interventions

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.

Patients Prescribed Clozapine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 150 unique subjects are required for the collection of at least 150 of each a capillary fingerstick blood, venous serum, and venous K2EDTA blood samples. A subset of at least 75 subjects will require two fingerstick blood samples. Subjects consisting of males and females, at least 21 years of age or older, who meet the protocol Inclusion / Exclusion criteria as described below.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saladax Biomedical, Inc.: lead
• Northwell Health: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Saladax Biomedical, Inc.

Bethlehem, Pennsylvania, 18015, United States

Location

Study Officials

• Robert Christenson

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: November 12, 2022
• Primary Completion: January 25, 2023
• Study Completion: May 16, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

US (1)