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Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Official Title  ADHD Symptoms in Autism: Cognition, Behavior, Treatment
Brief Summary

This study will first examine the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) and who do and do not have additional symptoms of attention deficit hyperactivity disorder (ADHD). The study will then examine the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD.

Detailed Description

Attention Deficit Hyperactivity Disorder (ADHD) is a major comorbid psychiatric disorder in children with Autism Spectrum Disorders (ASD) that significantly undermines behavioral, social, and emotional adjustment. Although the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) does not specifically allow for a comorbid diagnosis of ADHD with ASD, many children with an ASD manifest symptoms of ADHD and are treated for it with stimulants or other medication. The few studies on ADHD in ASD have not consistently established its cognitive and behavioral manifestations, or the optimal parameters for treatment. The proposed project will address these issues through studies of cognitive and behavioral functioning in children with ASD, with and without ADHD, and through a study of medication treatment of ADHD symptoms in autism.

Two groups of participants between the ages of 7 to 12 will participate in the initial phase of the study to examine the differences in children who have an Autism Spectrum Disorder with or without additional symptoms of ADHD. In one group, participants will qualify for a diagnosis of an Autism Spectrum Disorder (Autistic Disorder, Asperger's Disorder, and Pervasive Developmental Disorder-Not Otherwise Specified) and will also have symptoms of ADHD (ASD/ADHD), while in the second group, participants will have an Autism Spectrum Disorder, without symptoms of ADHD (ASD/non-ADHD group). All participants will undergo an initial psychological testing session that includes standardized measures of intellectual, adaptive behavior, language, behavioral, and emotional functioning, along with standardized diagnostic measures to confirm their diagnoses of ASD and/or ADHD (Visit 1). Children with intelligence quotients (IQs) below 50 or greater than 130 or with major sensory, motor, neurological, genetic, or psychiatric disorders that may interfere with testing will be excluded. The participants who meet eligibility criteria will complete computerized tasks of attentional functioning in a second visit (Visit 2).

A subset of the children from the ASD/ADHD group (N=24) will be invited to participate in a six-week randomized double-blind, placebo-controlled treatment trial using various doses (low, medium, or high dose) of methylphenidate (MPH). Children who are invited to participate in the treatment trial will be those who qualified based on the initial phase and who do not have any physical contraindications to MPH (e.g., history of MPH intolerance). In each week of the treatment trial, the child will take one of the three doses of MPH or a placebo. At the end of each week the child will be brought into the clinic by the parent for a medical check-up, parent interviews about the child's behavior and functioning that week, and computerized cognitive testing. Additionally, the child's parent and teacher will be asked to complete questionnaires about the child's behavior each week, so that the child's home and school behaviors at each MPH dose can be assessed.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary Outcome Measure  Conners' Teacher Rating Scale-Revised (CTRS-R) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Continuous Performance Test (CPT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Matching Familiar Figures Test (MFFT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Speeded Classification Task (SCT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Delay of Gratification Task (DOG) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Conners' Parent Rating Scale (CPRS)-Short Form [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Side Effects Questionnaire-Parent Version [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: Yes ]
Aberrant Behavior Checklist [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
ADDH Comprehensive Teacher Rating Scale [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Side Effects Questionnaire-Teacher Version [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: Yes ]
Clinician ratings on the Clinical Global Impressions Scale [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Selective Listening Tasks (pediatric speech intelligibility and dichotic listening tasks) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Stop Signal Test [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ]
Condition  Autism
Attention Deficit Disorder With Hyperactivity
Intervention  Drug: Methylphenidate-extended release
Drug: Methylphenidate-instant release
Other: Placebo
MEDLINE PMIDs
Links Click here for more information on this study on the Clinic Website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  72
Start Date  September 2005
Completion Date May 2010
Eligibility Criteria 

Inclusion Criteria:

Autism/ADHD Group:

  • DSM-IV diagnosis of autistic disorder, as per the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS)
  • Child manifests current symptoms of ADHD

Autism/non-ADHD Group:

  • Meets the diagnostic criteria for autism, as above, but does not meet the diagnostic criteria for ADHD

Exclusion Criteria:

In both groups, exclusion criteria will include:

  • Sensory or motor deficits sufficient to interfere with testing (e.g., blindness, severe cerebral palsy)
  • Serious neurological disorders (e.g., epilepsy, stroke)
  • Down syndrome, fragile X syndrome, Tourette syndrome, or fetal alcohol syndrome
  • Bipolar disorder or a family history of bipolar disorder in a first-degree relative
  • Other serious psychopathology that resulted in psychiatric hospitalization (e.g., for psychotic episode). The investigators will screen for this using the Diagnostic Interview for Children and Adolescents (DICA)-IV, and getting a complete developmental/medical history
  • Serious physical handicaps that would interfere with performance on laboratory tasks
  • IQ less than 50 and greater than 130
  • Verbal mental age (VMA) less than 36 months (to exclude participants unable to understand simple task instructions)

In the autism/ADHD group, further exclusion criteria apply to the MPH trial:

  • History of intolerance to MPH
  • Weight less than 20 kg or greater than 59 kg (less than 44 pounds or greater than 130 pounds)
  • Concomitant use of dextroamphetamine preparations (Dexedrine, Dextrostat), mixed amphetamine salts (Adderall XR), other MPH preparations (e.g., Concerta, Metadate); venlafaxine, bupropion, atomoxetine, guanfacine, modafinil.
  • Concomitant use of any herbal preparations
  • Medical condition for which stimulants are contraindicated (e.g., high blood pressure)
  • Past treatment failure on a methylphenidate trial
Gender Both
Ages 7 Years to 12 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Rosleen Mansour, MA     713-500-2580     Rosleen.Mansour@uth.tmc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00178503
Organization ID R01 MH72263
Secondary IDs †† DDTR B2-NDA
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Deborah A. Pearson, PhD     The University of Texas Health Science Center, Houston    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date January 2008
First Received Date  September 12, 2005
Last Updated Date July 2, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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