A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH); No intervention
Intervention description: Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance.; Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 194.0
Sex: All
Minimum age: 7 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate Hydrochloride; CONCERTA

Summary:

      The purpose of this long term post-marketing study is to evaluate the effectiveness and
      safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in
      participants with Attention Deficit Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADHD children must sign the consent form in person, and their parents or guardian must
             endorse, in the consent form, participation of the child in the designated research
             program

          -  Through personal interaction and assessment questionnaire, examine to determine
             compliance of DSM-IV ADHD diagnostic criteria

          -  According to the judgment of researchers, the ADHD children should have normal
             intelligence. Normal intelligence is defined as no obvious evidence of mental
             retardation in general (specific learning disabilities will not be considered mental
             retardation in general), formal IQ test to be conducted and 85 marks or above ought to
             be scored

          -  ADHD children should not have been subjected to psychotropic drug treatment within 6
             months. Those ADHD children on whom methylphenidate immediate-release tablets
             treatment is effective (with maximum daily dosage of 60 mg), may be admitted

          -  Normal children with IQ greater than or equal to 85

        Exclusion Criteria:

          -  Unable to fully comply with the cognitive function test in the laboratory

          -  Known to be allergic to methylphenidate

          -  Consumption of psychoactive drugs currently or in the past 30 days, including use of
             monoamine oxidase inhibitors, clonidine, other alpha 2 adrenergic receptor agonists,
             tricyclic antidepressants, theophylline, bishydroxycoumarin etc

          -  History of alcohol, drugs or substances abuse

          -  Have medical history of type I or II bipolar affective disorder, anxiety disorder,
             schizophrenia or pervasive developmental disorder