Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Condition: Autism; Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study examined the cognitive and behavioral differences in children who have an autism
      spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined
      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.

      Participants between the ages of 7 to 12 with an autism spectrum disorder participated in the
      initial phase of the study to examine the nature and effects of ADHD symptoms on behavioral
      and cognitive functioning. Participants underwent an initial psychological testing session
      that included 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 were be excluded. The participants who meet
      eligibility criteria completed computerized tasks of attentional functioning in a second
      visit (Visit 2).

      A subset of the children meeting criteria for the ASD/ADHD group (N=24) participated in a
      six-week randomized double-blind, placebo-controlled treatment trial using various doses
      (low, medium, or high dose) of methylphenidate (MPH). Children participated 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 children took one of the three doses of MPH or a placebo. At the end of each week
      the child were evaluated in the clinic by including 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 completed questionnaires about the child's
      behavior each week, so that the child's home and school behaviors at each MPH dose could be
      assessed.
    

Intervention name(s): Methylphenidate-extended release; Methylphenidate-immediate release; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.; Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.; Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.
Other intervention name(s): Ritalin LA
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment