What is the influence on the amount of clozapine in a patient's blood when clozapine is used once daily instead of twice daily?
- Conditions
- SchizophreniaMedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-004834-26-NL
- Lead Sponsor
- Albert Schweitzer hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 50
?Age =18 – 65 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
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
?‘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:
oFluvoxamine
oHormonal anti-conceptive,
oCiprofloxacin,
oPhenytoin,
oValproic acid,
oCarbamazepine
oRifampicin.
?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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method