Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Child Development Disorders, Pervasive |
Drug: Risperidone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD) |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2003 |
| Study Completion Date: | March 2005 |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 21 Years |
| Genders Eligible for Study: | Both |
| 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| 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 | |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00166595 History of Changes |
| Other Study ID Numbers: | PPRU 10545s |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 4, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Risperidone Autism Pervasive Developmental Disorder (PDD) |
Additional relevant MeSH terms:
|
Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013