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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
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)

Tracking Information
First Submitted Date  ICMJE October 23, 2001
First Posted Date  ICMJE October 24, 2001
Last Update Posted Date July 28, 2009
Study Start Date  ICMJE October 2001
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
hyperactivity, impulsiveness, and distractibility
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00025779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
Official Title  ICMJE Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Disorder With Hyperactivity
  • Autistic Disorder
  • Pervasive Development Disorders
Intervention  ICMJE
  • Drug: methylphenidate
  • Drug: guanfacine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00025779
Other Study ID Numbers  ICMJE N01 MH70009
N01 MH80011
N01 MH70010
N01 MH70001
DSIR CT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Mental Health (NIMH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eugene Arnold, MD Ohio State University
Investigator: Larry Scahill, Ph.D Yale University
PRS Account National Institute of Mental Health (NIMH)
Verification Date August 2008

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