NCT02625103

The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.

The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Anders Fink-Jensen, MD, DMSci · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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 .

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration
DRUG	Clozapine	Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2015-12-09
• Last updated: 2016-02-25

Locations

1 site across 1 country: Denmark