Schizophrenia Clinical Trial
Official title:
Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics in Schizophrenic Patients
Clozapine (Clz), an atypical antipsychotic, is the reference medication for patients with
treatment-resistant schizophrenia. Due to the high inter-individual variability of its
pharmacokinetics and its narrow therapeutic index, a close therapeutic drug monitoring (TDM)
of Clz is highly recommended.
Several factors can cause a variation in the pharmacokinetics as age, smoking habits, coffee
consumption and drug interaction. Genetic factors related to hepatic expression levels of the
cytochrome P450 (CYP), regulate the hepatic clearance of Clz, thereby determine its
bioavailability.
The CYP1A2 and CYP2C19 isoenzymes are mainly responsible for the metabolism of several drugs
including Clz. It has been demonstrated that there is an interethnic variation in the
expression and function of these two isoenzymes. This variation is caused by single
nucleotide polymorphisms (SNPs) of genes encoding these proteins.
While the Influence of the different polymorphisms related to CYP1A2 and CYP2C19 have been
established especially in Asian and Caucasian populations, no study has examined the impact
of these SNPs in the southern Mediterranean populations. Moreover, the impact of these SNPs
is very controversial. The present study aims to investigate in Tunisian schizophrenic
patients, the influence of genetic (CYP1A2 and CYP2C19 polymorphisms) and non-genetic factors
on Clz pharmacokinetics.
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