A Comparative Effectiveness Study Evaluating OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder in Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness (onset of effect, time to loss of
      effect, and overall efficacy) of methylphenidate given as an OROSÂ® (methylphenidate HCl)
      formulation, compared to immediate-release RitalinÂ® and placebo for the treatment of
      Attention Deficit Hyperactivity Disorder (ADHD) in children using standardized attention and
      behavior scales, and other assessments. Both OROSÂ® Methylphenidate HCl and RitalinÂ® contain
      the central nervous system stimulant, methylphenidate HCl.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral
      disorder in children, affecting 3% to 5% of the school-age population. This is a
      double-blind, double-dummy, randomized, placebo-controlled, active-controlled, crossover
      trial in children with ADHD, to compare the safety and effectiveness (onset of effect, time
      to loss of effect and overall efficacy) of OROS® Methylphenidate HCl with standard
      immediate-release Ritalin® and placebo. During this study, patients receive each of the three
      treatments (OROS® Methylphenidate HCl 18, 36 or 54 milligrams per day, Ritalin® 5, 10 or 15
      milligrams three times per day, or placebo) for 7 days, and are assigned to one of three
      dosage levels depending upon their prestudy methylphenidate dose and regimen. The total study
      participation for each patient will be 21 days. Since ADHD is manifested in a variety of
      settings and can affect attention and behavior, this study assesses efficacy in home,
      community school, and laboratory school settings using numerous assessments designed to
      evaluate various aspects of the disorder. These assessments are completed by a variety of
      raters, including the parents/caregivers, community school teachers, laboratory school
      teachers and the laboratory school counselor. The primary measure of effectiveness is the
      community school teacher's rating on the IOWA Conners Inattention/Overactivity subscale.
      Additional measures of effectiveness include IOWA Conners (Inattention/Overactivity and
      Oppositional/Defiance subscale) ratings, SKAMP attention and deportment ratings, peer
      interaction and other behavioral ratings, global assessments, accuracy and productivity of
      independent assigned academic seatwork, and assessments of positive and negative social
      behaviors, classroom rule violations and disruptive behaviors. Safety evaluations include the
      incidence of adverse events, vital signs, sleep quality, appetite, and the presence/severity
      of tics (hard-to-control, repeated twitching of any parts of the body or hard-to-control
      repeating of sounds or words). Patients will be given oral doses of: OROS® (methylphenidate
      HCl) either 1, 2 or 3 of the 18 milligram tablets once daily, Ritalin® 5, 10, or 15 mg
      (encapsulated/single capsule) three times per day, or placebo. There are three treatment
      groups, each group dosing for 7 days for a total of 21 days on study.
    

Intervention name(s): Ritalin; OROS Methylphenidate HCl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; OROS®; Ritalin®; children; methylphenidate; ADHD