NCT00166595

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 4 Years – 21 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Child Development Disorders, Pervasive

Interventions

Type	Name	Description
DRUG	Risperidone

Timeline

• Start date: 2003-02-01
• Completion: 2005-03-01
• First posted: 2005-09-14
• Last updated: 2014-01-28

Locations

4 sites across 1 country: United States