schizophrenia, clozapine, pharmacokinetics, dose interval, protein binding Schizofrenie, clozapine, farmacokinetiek, doseerfrequentie, eiwitbinding
Conditions
Interventions
At the study day(s), multiple blood samples will be drawn from the included patients. Sampling times depend on the patient’s clozapine dosing regimen.
In addition, a standardised assessment tool for
Sponsors
Albert Schweitzer hospital, Dordrecht, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria:  Age ≥18 – 65 years  Clozapine use BID or OID *1  Capacity to speak and read the Dutch language.  Mental competency and decisional capacity with regard to participation in the current study *2  Absence of active suicidality *2  Clozapine use in ‘steady state’ (i.e. same dose and frequency for ≥7 days)  Informed consent  Admission to the same ward or assisted living accommodation for ≥7 days *3
Exclusion criteria
Exclusion criteria:  ‘inbewaringstelling’ (IBS)  ‘rechterlijke machtiging’ (RM)  Pregnancy (if known)  Initiation, cessation or dose change of the following co-medication within 7 days prior to blood sampling: o Fluvoxamine o Hormonal anti-conceptive, o Phenytoin, o Valproic acid, o Carbamazepine o Rifampicin.  Acute inflammation / infection (derived from having fever (i.e. body temperature >38 degrees Celsius and/or using an antibiotic at time of blood sampling).  Smoking initiation or cessation < 7 days before participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters assessed are the total and unbound clozapine and norclozapine plasma concentrations at specified time points. With these concentrations characterised PK parameters as well as metabolic ratio and protein binding of clozapine and norclozapine in OID and BID dosing regimens, will be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of clozapine | — |
Contacts
Public ContactM.M. Beex-Oosterhuis
Albert Schweitzer ziekenhuis
Outcome results
None listed