CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted
Drug / intervention
methylphenidate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00025779
NCT00025779N/ACompleted
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Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders

National Institute of Mental Health (NIMH)·interventional·Posted Oct 24, 2001·Updated Jul 28, 2009

In Brief

A clinical study evaluating methylphenidate and guanfacine for Attention Deficit Disorder With Hyperactivity and 2 related conditions. Completed, across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity, Autistic Disorder, Pervasive Development Disorders
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2001
Enrollment StartOct 1, 2001
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 24.7 years ago

Interventions

methylphenidatedrug

guanfacinedrug