Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

Completed · Not applicable

Conditions studied: Attention Deficit Disorder With Hyperactivity, Autistic Disorder, Pervasive Development Disorders

In brief

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).

Key facts

Study ID

NCT00025779

Run by

National Institute of Mental Health (NIMH)

People needed

60

Starts

2001-10-01

Last updated by the study team

2009-07-28

Who can join

Age: 5 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

Where it is running

• UCLA Neuropsychiatric Institute — Los Angeles, California, United States
• Yale Child Study Center — New Haven, Connecticut, United States
• Indiana University-Riley Hospital for Children — Indianapolis, Indiana, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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