Schizophrenia MedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: clozapine
Pharmaceutical Form:
INN or Proposed INN: clozapine
CAS Number: 5786-21-0
Other descriptive name: CLOZAPINE
Sponsors
Albert Schweitzer hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess the differences in the pharmacokinetic properties of clozapine and norclozapine when clozapine is used OID or BID in psychiatric patients, examining both clozapine and norclozapine concentrations and its unbound fractions and total concentrations. Ultimately, the knowledge of the full pharmacokinetic profile will facilitate in developing an evidence based therapeutic window for clozapine when used OID. ;Secondary Objective: We will explore the influence of dose frequency on the frequency or discomfort of clozapine’s side effects using the self-rating version of the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale (UKU-SERS-Pat). ;Primary end point(s): The main study parameters are the total and unbound clozapine and norclozapine plasma concentrations at specified time points. With these concentrations characterised pharmacokinetic profiles as well as metabolic ratio and protein binding of clozapine and norclozapine in OID and BID dosing regimens, will be determined. ; Timepoint(s) of evaluation of this end point: • T = 0 hours (just before clozapine intake) = trough concentration • T = 30 minutes = absorption phase begins • T = 2 hours and 4 hours = maximum concentration (Cmax) is expected to be reached after 1-3 hours • T = 8 hours = for BID dosing, this time point will be on the slope between the Cmax and the trough concentration • T = 12 hours = for OID dosing, this time point will be halfway the concentration time curve; for BID dosing, the concentration at t=12 hours is expected to be equal to the concentration at t= 0 hours (trough concentration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The frequency or discomfort of clozapine’s side effects using the self-rating version of the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale (UKU-SERS-Pat) will also be assembled.;Timepoint(s) of evaluation of this end point: The frequency or discomfort of clozapine’s side effects using the self-rating version of the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale (UKU-SERS-Pat) will be assembled once during the study day. | — |
Countries
Netherlands
Contacts
Public ContactM.M. Beex-Oosterhuis, PharmD
Albert Schweitzer hospital
Outcome results
None listed