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

January 27, 2014 updated by: Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan/Wayne State University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43210-1296
        • The Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRU 10545s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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