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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT00166595

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

100

Enrollment

Locations

24.9

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Disorders, Pervasive	Drug: Risperidone	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2003

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Michigan/Wayne State University	Detroit	Michigan	United States	48201
2	Duke University Medical Center	Durham	North Carolina	United States	27705
3	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
4	The Ohio State University Medical Center	Columbus	Ohio	United States	43210-1296