A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Dex-methylphenidate hydrochloride extended-release (Focalin XR); Placebo
Intervention description: 20 mg capsule orally once a day for 7 days; orally once a day for 7 days
Intervention MeSH terms: Methylphenidate; Dexmethylphenidate Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; children; laboratory classroom; Attention Deficit Hyperactivity Disorder

Summary:

      This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo
      during an 8-hour laboratory classroom day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 6-12 years, inclusive.

          -  Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the
             K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and
             Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to
             possible co-morbidity, the subject will not be enrolled into the study.

          -  Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg
             methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to
             screening visit (Concerta® 36 mg and 54 mg is allowable)

        Exclusion Criteria:

          -  Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for
             Parents (CADS-P) and the Daily Diary Card

          -  Diagnosed with a tic disorder or Tourette's syndrome

          -  History of seizure disorder

          -  The presence of a known medical condition that would preclude the use of
             methylphenidate. A history (within the past year) or presence of clinically
             significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal,
             pulmonary, immunological, hematological, endocrine, or neurological disease

          -  ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening

          -  A history of psychiatric illness or substance use disorder (e.g., schizophrenia,
             bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or
             severe Oppositional defiant disorder)

          -  Subjects who have participated in an investigational trial within the past 4 weeks (28
             days) are excluded

          -  Subjects who are currently taking antidepressants or other psychotropic medication

          -  Subjects who have initiated psychotherapy during the three months prior to
             randomization

          -  Subjects with a positive urine drug screen

          -  Subjects who have a history of poor response or intolerance to methylphenidate or
             d-methylphenidate

        Other protocol defined inclusion/exclusion criteria may apply