Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

Completed · Phase 1

Conditions studied: Child Development Disorders, Pervasive

In brief

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 and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.

Key facts

Study ID

NCT00147394

Run by

Children's Hospital Medical Center, Cincinnati

People needed

100

Starts

2001-12-01

Expected to finish

2004-06-01

Last updated by the study team

2012-10-29

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Michigan/Wayne State University — Detroit, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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