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

Child Development Disorders, Pervasive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166595
• Other study ID #: PPRU 10545s
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: January 27, 2014
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: July 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 21 Years

Eligibility

Inclusion Criteria:

• Male and female patients between the ages of 4 and 21 years.

• Patients meeting DSM-IV criteria for autistic disorder, Pervasive Developmental Disorder (PDD), or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS) and about to initiate clinical treatment or currently clinically treated with risperidone.

• Patients about to initiate clinical treatment or currently clinically treated with risperidone, or currently on risperidone as a participant in one of the multi-site Research Unit for Pediatric Psychopharmacology (RUPP) protocols.

Exclusion Criteria:

• Children taking psychotropic or other medication that will significantly interact with target CYP 450 isoenzyme activity, such to the discretion of the principal investigator (PI).

• Patients with known renal or hepatic dysfunction (e.g. serum creatinine, and transaminases or bilirubin exceeding age specific upper range limits) are not eligible.

• Failure of the parent/legal guardian to give informed consent.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

Drug:
• Risperidone

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Children's Hospital of Michigan/Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

•   Pediatric Pharmacology Research Unit Website