Does dose frequency influence the plasma concentration of clozapine and norclozapine in psychiatric patients in the Netherlands?
Completed
- Conditions
- schizophrenia, clozapine, pharmacokinetics, dose interval, protein bindingSchizofrenie, clozapine, farmacokinetiek, doseerfrequentie, eiwitbinding
- Registration Number
- NL-OMON26619
- Lead Sponsor
- Albert Schweitzer hospital, Dordrecht, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Age ≥18 – 65 years
Clozapine use BID or OID *1
Exclusion Criteria
‘inbewaringstelling’ (IBS)
‘rechterlijke machtiging’ (RM)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>
- Secondary Outcome Measures
Name Time Method Side effects of clozapine