Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00025779
First received: October 23, 2001
Last updated: July 24, 2009
Last verified: August 2008
  Purpose

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).


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Autistic Disorder
Pervasive Development Disorders
Drug: methylphenidate
Drug: guanfacine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • hyperactivity, impulsiveness, and distractibility

Estimated Enrollment: 60
Study Start Date: October 2001
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025779

Locations
United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90024
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
United States, Indiana
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21231
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Study Chair: Eugene Arnold, MD Ohio State University
Investigator: Larry Scahill, Ph.D Yale University
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00025779     History of Changes
Other Study ID Numbers: N01 MH70009, N01 MH80011, N01 MH70010, N01 MH70001, DSIR CT
Study First Received: October 23, 2001
Last Updated: July 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Hyperactivity
Distractibility
Impulsiveness
Pervasive Development Disorders

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Guanfacine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on April 23, 2014