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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00166595 |
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 |
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Child Development Disorders, Pervasive |
Drug: Risperidone |
Phase I |
Study Type: | Interventional |
Study Design: | 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.
Ages Eligible for Study: | 4 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | PPRU 10545s |
Study First Received: | September 9, 2005 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00166595 |
Health Authority: | United States: Federal Government |
Risperidone Autism Pervasive Developmental Disorder (PDD) |
Developmental Disabilities Child Development Disorders, Pervasive Dopamine Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Risperidone Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |