The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OROS Methylphenidate
Intervention description: Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Attention Deficit Disorder With Hyperactivity; Methylphenidate; Concerta

Summary:

      The purpose of this study is to evaluate whether familial relationships and psychological
      status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder
      (ADHD) symptoms of participants can be improved by switching from Immediate-release
      Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)
             according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
             (DSM-IV)

          -  Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for
             at least 4 weeks before enrollment, but previous treatment is considered
             unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack
             of tolerability or safety, lack of compliance, and/or other reasons

          -  Participants who are able to comply with the study visit schedule and whose
             parents/caregiver and community school teacher are willing and able to complete the
             protocol-specified assessments

          -  Participants who are still at school

          -  Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily
             before enrollment

        Exclusion Criteria:

          -  Participants who cannot understand or follow the instructions given in the study

          -  Participants with serious or unstable medical illness

          -  Participants who have clinically significant gastrointestinal problems, including
             narrowing of the gastrointestinal tract

          -  Participants who have glaucoma (increased pressure inside the eye that causes visual
             problems), an ongoing seizure disorders, or a psychotic disorder

          -  Participants who are hypersensitive to methylphenidate

          -  Participants who have any co-existing medical condition or are taking a concomitant
             medication that is likely to interfere with safe administration of methylphenidate