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The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring
The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose. The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .
Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them. The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine . In addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Psychiatric Centre Rigshospitalet
Copenhagen, København Ø, Denmark
Start Date
September 1, 2015
Primary Completion Date
December 1, 2015
Completion Date
February 1, 2016
Last Updated
February 25, 2016
48
ACTUAL participants
Blood sampling
PROCEDURE
Clozapine
DRUG
Lead Sponsor
Anders Fink-Jensen, MD, DMSci
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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