The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
- Registration Number
- NCT02625103
- Lead Sponsor
- Anders Fink-Jensen, MD, DMSci
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clozapine Clozapine treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration Clozapine Blood sampling treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration
- Primary Outcome Measures
Name Time Method Percentage change in serum-clozapine 10 - 14 hours post drug administration
- Secondary Outcome Measures
Name Time Method Percentage change in serum-clozapine (multiple shorter ranges) < 10 -14 hours post dose
Trial Locations
- Locations (1)
Psychiatric Centre Rigshospitalet
🇩🇰Copenhagen, København Ø, Denmark