Schizophrenia Clinical Trial
Official title:
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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