An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OROS Methylphenidate HCl
Intervention description: Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate hydrochloride; Methylphenidate; CONCERTA

Summary:

      The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic
      Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in
      Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th
             edition (DSM-IV) criteria for Attention Deficit Hyperactivity Disorder (ADHD) and are
             considered to require medication therapy

          -  Participants that agreed to observe visit schedules and willingly complete the
             evaluation defined by participant (possibly to be completed by parents/guardians)
             during the treatment period

          -  Participants and parents/guardians that are able to understand the participation
             procedures of the research and spontaneously request the discontinuation therein at
             any time

          -  Participants that offered spontaneous consent for participation

          -  Participants whose guardian/legal representative provided spontaneous written consent

        Exclusion Criteria:

          -  Hypersensitivity to methylphenidate HCl

          -  Participants diagnosed with major depression or anxiety disorders according to DSM-IV
             Diagnostic criteria and who requires drug therapy

          -  Participants with a history of bipolar disorder, psychotic disorder, and substance
             abuse disorder ordiagnosed with an overall developmental disorder, organic brain
             disorder, seizure (sudden, uncontrolled muscle spasms and loss of consciousness
             resulting from abnormal brain function) disorder, movement disorder requiring the
             medication therapy, or with a family history of Tourette's syndrome (a
             neuropsychological disorder that causes marked distress or significant impairment in
             social, occupational, or other important areas of functioning)

          -  Taken Osmotic Release Oral System (OROS) Methylphenidate within 3 months prior to
             screening

          -  Currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic,
             benzodiazepines, modafinil, anticonvulsant (drug used to stop seizures) or health food
             supplements that may have a central nervous system activity