Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

National Institutes of Health (NIH)

Status

Completed

Conditions

Pervasive Development Disorders

Autistic Disorder

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: methylphenidate

Drug: guanfacine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00025779

N01 MH80011

N01 MH70010

N01 MH70001

DSIR CT

N01 MH70009

Details and patient eligibility

About

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).

Full description

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.

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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