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

Anders Fink-Jensen, MD, DMSci

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Procedure: Blood sampling

Drug: Clozapine

Study type

Interventional

Funder types

Other

Identifiers

NCT02625103

2015-002520-82 (EudraCT Number)

CLO-MEAS

Details and patient eligibility

About

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 .

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 < 65
Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
Unchanged dose of clozapine for the last 30 days
Usual time of clozapine evening-dose administration between 9 and 12 pm.

Exclusion criteria

Significant drug or alcohol abuse that affects participation in this trial
Non- or partial compliance of clozapine the day before the trial (assessed by interview)
Unresponsive by telephone the evening before the trial
Consumption of clozapine in the morning on the day of the trial
Significant change in smoking habits within the last 30 days (assessed by interview)
Significant change of caffeine intake within the last 7 days (assessed by interview)
Modified use of other antipsychotics within the last 30 days
Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )
Females who are pregnant or breast-feeding