Child Development Disorders, Pervasive Clinical Trial
Official title:
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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