Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder|
- Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
- Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
|Study Start Date:||December 2001|
|Study Completion Date:||June 2004|
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 they are extremely debilitating and lack efficacious therapies. Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. Newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population.
This study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. Two additional visits with blood sampling will occur. The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2.
|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|
|Cincinnati, Ohio, United States, 45229|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106-6010|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1296|
|Principal Investigator:||Alexander Vinks, Pharm.D., Ph.D.||Children's Hospital Medical Center, Cincinnati|