Child Development Disorders, Pervasive Clinical Trial
Official title:
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.
To the knowledge of the investigators there are no studies documenting the pharmacokinetics
and pharmacogenetics of risperidone in children with PDD. Currently the PPRU network is
conducting a PK study whose aim is to establish a new enantio-selective micro-assay
methodology and to generate preliminary population PK data of risperidone and its
metabolites in PDD. This study focuses on pharmacogenetic evaluation of PDD patients having
little or no effect, those that are unusually sensitive and those experiencing drug
toxicity/adverse events at standard risperidone dosages.
In this study two 5 ml blood samples will be drawn at a regulary scheduled PK visit.
Alternatively pooled waste blood samples or a buccal swab can be obtained.
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Primary Purpose: Treatment
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