Status:
COMPLETED
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Child Development Disorders, Pervasive
Eligibility:
All Genders
5-16 years
Phase:
PHASE1
Brief Summary
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone...
Detailed Description
Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions. While these disorders are rare, they represent a significant public health problem because the...
Eligibility Criteria
Inclusion
- Male and female patients between ages of 5 and less than 17 years.
- Patients meeting DSM-IV criteria for PDD-NOS about to initiate clinical treatment or currently clinically treated with risperidone.
- Patients with autistic disorder or PDD-NOS currently on risperidone as a participant in one of the multi-site RUPP protocols.
Exclusion
- Children taking psychotropic or other medication that will interact with target CYP 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. CYP2D6 or CYP3A4; to be decided by the PI)
- Patients with known renal or hepatic dysfunction (e.g. serum creatinine \> 1.5 normal upper limit, transaminases or bilirubin \> 2 times normal upper limit)
- Failure of the parent/legal guardian to give informed consent.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00147394
Start Date
December 1 2001
End Date
June 1 2004
Last Update
October 29 2012
Active Locations (5)
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1
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, United States, 48201
2
Duke University Medical Center
Durham, North Carolina, United States, 27705
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
4
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-6010