Status:
COMPLETED
Clozapine Therapy Sample Collection - Method Comparison Study
Lead Sponsor:
Saladax Biomedical, Inc.
Collaborating Sponsors:
Northwell Health
University of Maryland, Baltimore
Conditions:
Patients Prescribed Clozapine
Eligibility:
All Genders
21+ years
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 concentr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT05422131
Start Date
November 12 2022
End Date
May 16 2023
Last Update
May 18 2023
Active Locations (1)
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1
Saladax Biomedical, Inc.
Bethlehem, Pennsylvania, United States, 18015