Clozapine Therapy Sample Collection - Method Comparison Study

Completed

• Conditions: Patients Prescribed Clozapine
• Interventions: Device: MyCare Insite Clozapine Test

• Registration Number: NCT05422131
• Lead Sponsor: Saladax Biomedical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Study Start: 2022-11-12
• Primary Completion: 2023-01-25
• Status Verified: 2023-05
• Study Completion: 2023-05-16
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Prescribed Clozapine	MyCare Insite Clozapine Test	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saladax Biomedical, Inc.; 🇺🇸 Bethlehem, Pennsylvania, United States