Status:
COMPLETED
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Child Development Disorders, Pervasive
Eligibility:
All Genders
4-21 years
Phase:
PHASE1
PHASE2
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 ...
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00166595
Start Date
February 1 2003
End Date
March 1 2005
Last Update
January 28 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
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 Medical Center
Cincinnati, Ohio, United States, 45229
4
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1296