Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in
      treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children.
      Virtually no data has been published on the use of long-acting stimulant preparations in very
      young children despite early symptomatic development in a significant portion of young
      children with ADHD. This would be one of the first studies looking at a long-acting
      preparation of a stimulant medication in the treatment of ADHD in very young children.

      Hypotheses

        1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.

        2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old
           children.
    

Detailed description: 
      This protocol involves an 8-week, open-label, pilot study evaluating the effectiveness,
      safety, and tolerability of Ritalin LA in treating Attention-Deficit/Hyperactivity Disorder
      (ADHD) in 4 and 5 year old children. The purpose of this study is to ascertain pilot data on
      the use of long-acting stimulants in preschool-age children since virtually no data exist on
      these medications in this population. The interventions include utilizing short-acting
      methylphenidate for the initial dosing and titration and then converting the children to
      Ritalin LA once an optimal dose has been found. Parents will also be receiving parent
      education training throughout the study. Evaluations will include obtaining the ADHD-IV at
      every visit, side effects of the medication, vital signs, EKG, physical exam, the Clinical
      Global Assessment Scale, and the Clinical Global Impression-Improvement and Severity Scales.
      This study will also assess parent stress with the Parent Stress Index and the emotional
      index of the children with the Expressed Emotion Scale for Children. Follow-up will be weekly
      during the first month and bi-weekly during the second month.
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention description(s): Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.
Other intervention name(s): Ritalin; Methylin; Ritalin LA
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Stimulant Treatment; Young Children