Methylphenidate Study in Young Children With Developmental Disorders
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Developmental Disabilities
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if methylphenidate (a common brand name is
      Ritalin), a medicine used for treating older children with Attention Deficit and
      Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of
      ADHD in young children with Developmental Disorders (DD)
    

Detailed description: 
      Currently, there is no systematic empirical information to guide the use of methylphenidate
      (a common brand name is Ritalin) to treat symptoms of ADHD in young children with Autistic
      Disorder/Asperger's Disorder/Pervasive Developmental Disorder, Not Otherwise
      Specified/Developmental Disorders. Preliminary data from a recent study of ADHD in young
      children suggest that methylphenidate may be useful in children with developmental disorders
      (DD). The purpose of this study is to determine the safety and efficacy of methylphenidate to
      treat ADHD symptoms in young children with Pervasive Developmental Disorders (PDD) or
      Developmental Disorders (DD).

      All subjects will be screened for eligibility inclusion and exclusion criteria. All
      concurrent non-pharmacological therapies will be stabilized for a minimum period of 2 weeks
      prior to the child's entry into the drug phase of the study. At each medication follow-up
      visit, a detailed history will be obtained and recorded for all concurrent treatments. If a
      child enrolls in this study, his/her participation will last approximately 3 to 4½ months
      with 12-18 outpatient daytime visits.

      Screening assessment: The child's parent and teacher/daycare provider, if applicable, will
      need to complete some forms that describe the child's problems with overactivity, impulsivity
      and inattention. If these forms indicate that the child may have ADHD the investigator will
      schedule outpatient-screening assessments. The research staff will evaluate the child to see
      if s/he has a Developmental Disorder (DD) or PDD and ADHD. Each child will receive a
      developmental assessment, and each parent will be interviewed about his or her child's
      behavior. The child's teacher will be given several rating forms to complete. The parents
      will be asked to complete some questions about the child's development. Both parents (if
      available) will be interviewed about their family histories. Some of the screening
      assessments will be videotaped/audiotaped. Each child will have a physical examination, an
      electrocardiogram (EKG), a urine test and a blood test. The doctor will ask the parents about
      his or her child's medical history.

      Medication phase: After screening assessments are completed, the child will enter the
      medication phase of the study. Each child will first have a step-wise single-blind titration
      of MPH to determine his/her best dose followed by a double-blind crossover trial with placebo
      and the child's best dose. The order of active drug and placebo will be randomized across the
      sample so that half the children will first receive MPH for 2 weeks and the other half will
      first receive placebo for 2 weeks. The children will receive the alternative drug condition
      (placebo or the child's best dose) for the next 2 weeks.

      The child and his/her parents will come back each week for a clinic visit. At each visit the
      child's height, weight, blood pressure and pulse will be checked. The child's parents and
      teacher/daycare provider, if applicable, will be asked to complete some rating scales every
      week.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): 1-week single blind placebo lead-in phase.
step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week.
Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects.
After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methylphenidate; ritalin; attention deficit hyperactivity disorder; developmental disorder; preschool children