Treatment-resistant schizophrenia MedDRA version: 18.1 Level: LLT Classification code 10039642 Term: Schizophrenic disorders System Organ Class: 100000004873
Conditions
Interventions
Trade Name: leponex
Pharmaceutical Form: Tablet
INN or Proposed INN: Clozapine
CAS Number: 5786-21-0
Other descriptive name: CLOZAPINE
Concentration unit: mg milligram(s)
Concentration type: range
Con
Sponsors
Prof., dr. med. Anders Fink-Jensen
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 . 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. 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactPsykiatrisk Afdeling O
Psykiatrisk Center København
Outcome results
None listed