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Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

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ClinicalTrials.gov Identifier: NCT00025779
Recruitment Status : Completed
First Posted : October 24, 2001
Last Update Posted : July 28, 2009
Information provided by:
National Institute of Mental Health (NIMH)

Brief 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).

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Autistic Disorder Pervasive Development Disorders Drug: methylphenidate Drug: guanfacine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Study Start Date : October 2001
Actual Primary Completion Date : November 2003

Primary Outcome Measures :
  1. hyperactivity, impulsiveness, and distractibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025779

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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
National Institute of Mental Health (NIMH)
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Study Chair: Eugene Arnold, MD Ohio State University
OverallOfficial: Larry Scahill, Ph.D Yale University
Additional Information:
Publications of Results:
Other Publications:

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ClinicalTrials.gov Identifier: NCT00025779    
Other Study ID Numbers: N01 MH70009
N01 MH80011
N01 MH70010
N01 MH70001
First Posted: October 24, 2001    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: August 2008
Keywords provided by National Institute of Mental Health (NIMH):
Pervasive Development Disorders
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents