Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Guanfacine; Methylphenidate

Criteria

• Diagnosis of PDD (including Asperger's Disorder and Autistic Disorder)

• Clinically significant symptoms of ADHD

• Mental age of at least 18 months

• Blood pressure within normal ranges for age and gender

• Weight 16 kg or more

• Absence of chronic tic disorder

• Absence of any medical condition that would be incompatible with the study treatments

• Absence of evidence of hypersensitivity to study treatments