An Effectiveness and Safety Study Evaluating OROS Methylphenidate Hydrochloride (HCl), Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
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 provide data on the effectiveness of the OROS Methylphenidate
      Hydrochloride (HCl) formulation compared to placebo and standard immediate-release Ritalin
      with respect to improving attention and behavior, and decreasing hyperactivity in children
      with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS Methylphenidate HCl and
      Ritalin contain the central nervous system stimulant, methylphenidate HCl. The safety
      associated with the two methylphenidate formulations will also be compared with placebo.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral
      disorder in children, affecting 3% to 5% of the school-age population. Behavioral
      pediatricians, child psychiatrists, and child neurologists indicate that referrals for ADHD
      may constitute up to 50% of their practices. This is a double-blind, double-dummy,
      randomized, placebo-controlled, active-controlled, 3-treatment, 3-period crossover trial to
      compare the safety and effectiveness (onset of effect, time to loss of effect and overall
      efficacy) of OROS Methylphenidate Hydrochloride (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, and laboratory school teachers. The primary
      measure of effectiveness is the community school teacher's rating on the IOWA Conners
      Inattention/Overactivity subscale. Additional measures of effectiveness include the IOWA
      Conners (Inattention/Overactivity and Oppositional/Defiance subscale) ratings, SKAMP
      attention and deportment ratings, peer interaction and other behavioral ratings, global
      assessments, SNAP-IV ratings, activity levels during structured activities, accuracy and
      productivity of independent assigned academic seatwork, and a home situation questionnaire.
      Safety evaluations include the incidence of adverse events, physical examinations, clinical
      laboratory tests, vital signs, sleep quality, actigraphy (sleep latency, duration, and
      arousals), 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) 1, 2, or 3 of the 18-milligram tablets once
      daily, or Ritalin 5, 10, or 15 mg (encapsulated/single capsule) three times a 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): Placebo; OROS (methylphenidate HCl); Ritalin (methylphenidate)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment C: Three OROS placebo tablets once daily + 1 placebo capsule 3x times/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.; Treatment A: 1, 2, or 3 OROS methylphenidate 18-mg tablets + 0, 1, or 2 OROS placebo tablets (3 tablets in total) once daily + 1 placebo capsule 3x/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.; Treatment B: 5, 10, or 15-mg tablets (encapsulated/single capsule) 3 times a day + 3 OROS placebo tablets once daily for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; OROS; children; methylphenidate; Ritalin