drugset / Trial / NCT00025779

Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

NCT00025779

RandomizedCrossoverDouble-blindTreatment

Summary

This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).

Timeline

Start
2001-10
Primary completion
2003-11
Completion

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule
Subject Methylphenidate Small molecule