Influence of dose interval on the pharmacokinetics of both unbound and total fractions of clozapine and norclozapine in psychiatric patients in the Netherlands
- Conditions
- psychosisSchizophrenia10039628
- Registration Number
- NL-OMON48672
- Lead Sponsor
- Albert Schweitzer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
* Age *18 * 70 years
* Clozapine use BID or OID
* Capacity to speak and read the Dutch language.
* Mental competency and decisional capacity with regard to participation in the current study
* Absence of active suicidality
* Clozapine use in *steady state* (i.e. same dose and frequency for *7 days)
* Signed Informed consent
* *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 Ciprofloxacin,
o Phenytoin,
o Valproic acid,
o Carbamazepine
o Rifampicin.
* Acute inflammation / infection (derived from having fever (i.e. body temperature >38.0 degrees Celsius and/or using an antibiotic at time of blood sampling).
* Smoking (of tobacco containing products) initiation or cessation < 7 days before participation
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the total and unbound clozapine and norclozapine<br /><br>plasma concentrations at specified time points. With these concentrations<br /><br>characterised pharmacokinetic profiles as well as metabolic ratio and protein<br /><br>binding of clozapine and norclozapine in OID and BID dosing regimens, will be<br /><br>determined. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the frequency or discomfort of clozapine*s side<br /><br>effects.</p><br>