Clozapine Therapy Sample Collection - Method Comparison Study

Saladax Biomedical

Status: Completed

Conditions: Patients Prescribed Clozapine

Treatments: Device: MyCare Insite Clozapine Test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05422131

SBI-CLZ-002

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

153 participants in 1 patient group

Patients Prescribed Clozapine

Treatment:

Device: MyCare Insite Clozapine Test