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

Primary Purpose

Child Development Disorders, Pervasive

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Development Disorders, Pervasive focused on measuring Risperidone, Autism, Pervasive Developmental Disorder (PDD)

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital of Michigan/Wayne State University
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • The Ohio State University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
January 27, 2014
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00166595
Brief Title
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Official Title
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders, Pervasive
Keywords
Risperidone, Autism, Pervasive Developmental Disorder (PDD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital of Michigan/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1296
Country
United States

12. IPD Sharing Statement

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

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