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

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ClinicalTrials.gov Identifier: NCT00166595
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 28, 2014
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Primary Purpose: Treatment
Official Title: Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Study Start Date : February 2003
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166595

United States, Michigan
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, United States, 48201
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1296
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information

Additional Information:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00166595     History of Changes
Other Study ID Numbers: PPRU 10545s
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: July 2012

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pervasive Developmental Disorder (PDD)

Additional relevant MeSH terms:
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents