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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

October 23, 2001
July 24, 2009
October 2001
November 2003   (final data collection date for primary outcome measure)
hyperactivity, impulsiveness, and distractibility
Same as current
Complete list of historical versions of study NCT00025779 on ClinicalTrials.gov Archive Site
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Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
Methylphenidate for Hyperactivity and Impulsiveness 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).

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Attention Deficit Disorder With Hyperactivity
  • Autistic Disorder
  • Pervasive Development Disorders
  • Drug: methylphenidate
  • Drug: guanfacine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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November 2003   (final data collection date for primary outcome measure)
  • 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
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00025779
N01 MH70009, N01 MH80011, N01 MH70010, N01 MH70001, DSIR CT
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National Institute of Mental Health (NIMH)
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Study Chair: Eugene Arnold, MD Ohio State University
Investigator: Larry Scahill, Ph.D Yale University
National Institute of Mental Health (NIMH)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP