The significance of deviation in time from the 12-hour standard serum-clozapine monitoring
- Conditions
- Treatment-resistant schizophreniaMedDRA version: 18.1Level: LLTClassification code 10039642Term: Schizophrenic disordersSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-002520-82-DK
- Lead Sponsor
- Prof., dr. med. Anders Fink-Jensen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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 administration of the clozapine evening-dose between 21:00 and 24:00
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Significant abuse that affects participation in this trial
• Non- or partial compliance of clozapine the day before the trial (judged by interview)
• can not be contacted by telephone the evening before the test
• Has taken clozapine in the morning on the day of the trial
• Significant change in smoking habits within the last 30 days ( rated at interview)
• Significant change of caffeine intake within the last 7 days ( rated at interview)
• Modified use of other antipsychotics within the last 30 days
• Within the last 30 days (7 days for hormone based contraceptives) changed use of other medications that can affect s- clozapine during the trial :
- medications that increases s-clozapine ( fluvoxamine, ciprofloxacin , hormone based contraceptives)
- medications that lowers s-clozapine ( carbamazepine , phenytoin , rifampicin, omeprazole )
• Females who are pregnant or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the significance of deviation in time from the 12-hour standard blood sampling timepoint when Therapeutic Drug monitoring (TDM) clozapine;Secondary Objective: To describe changes of s-clozapine and s-N-desmethyl-clozapine within the range 10-14 hours after the last administration of clozapine .<br>To describe what covariates that might affect the change of s-clozapine and s-N-desmethyl clozapine, including gender, age , BMI, co-medications, signs of infection, caffeine intake and smoking;Primary end point(s): Primary endpoint is the relative change in s-clozapine and s-N-desmethyl clozapine over time , within the range of 10 to 14 hours after last clozapine administration.<br>In addition the ratio between clozapine and N- desmethyl clozapine throughout the trial will be calculated.;Timepoint(s) of evaluation of this end point: Evaluation takes place when inclusion has ended and after the simultaneous blood analysis
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Subgroup analyzes will be performed in order to characterise any groups with particularly high or low risk of significant s-clozapine changes.;Timepoint(s) of evaluation of this end point: When inclusion has ended