Clinical trial NCT02625103: The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
Official title: The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia, Clozapine, TDM, Serum Concentration
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Rigshospitalet, Denmark
First posted: 2015-12-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in serum-clozapine
timeFrame: 10 - 14 hours post drug administration
Secondary outcomes:
measure: Percentage change in serum-clozapine (multiple shorter ranges)
timeFrame: < 10 -14 hours post dose
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Centre Rigshospitalet
state: København Ø
Study officials:
affiliation: Psychiatric Centre Rigshospitalet
name: Anders Fink-Jensen, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References: