Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

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).

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Impulsive Behavior Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Pervasive Development Disorders Signs and Symptoms Spasm

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Neuropsychiatric Institute, Los Angeles, California, United States

About this study

The safety and efficacy of methylphenidate (MPH) in 60 children and adolescents with PDD and behavioral difficulties (such as hyperactivity, impulsiveness and distractibility) will be evaluated in a multi-dose, 4-week randomized, crossover, placebo-controlled study. The MPH study has three parts: a Test-Dose Period, a Double-Blind trial and an 8-Week Extension Period (open-label). After a screening visit, eligible children will start a 1-week Test-Dose Period. During this week, each child will be given the three MPH doses that are used in the Double-Blind trial to make sure there are no serious side effects. If problems are encountered at the high dose level, that dose will not be given in the Double-Blind phase. The Double-Blind phase lasts 4 weeks and consists of three different MPH dose levels and a week of placebo. Each treatment/dose is given for 1 week, and neither the researcher nor the participants' families will know whether the medication is placebo or MPH. Children who do well during this phase will continue on the best dose of MPH (determined during the Double-Blind phase) for an additional eight weeks (open-label).

Those who do not show significant improvement during the Double-Blind phase, do not tolerate MPH during the Test Dose Period, or are not able to take MPH before beginning the study are offered open-label treatment with guanfacine for 8 weeks.

Prior to randomization in the MPH trial OR entry into the open-label guanfacine trial, there will be a medication-free period for children who are currently on medication. The withdrawal will be conducted in clinically appropriate way (depending on drug and duration of treatment) to minimize withdrawal effects. This period is to establish a drug-free baseline measurement and to minimize drug-drug interaction. No participant will be withdrawn from a currently effective medication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Guanfacine

Drug

Primary outcomes

hyperactivity, impulsiveness, and distractibility

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Official study title

Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders

Important dates

Study start: 2001
Primary completion: 2003
First posted: Oct 24, 2001
Registry last updated: Jul 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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