Clinical Trial: Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: September 9, 2005
Date Started: February 2003
Date Completion:
Last Updated: January 27, 2014
Last Verified: July 2012