Clinical Trial: An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effectiveness of CONCERTA® vs. Usual Clinical Care With Immediate Release Methylphenidate (IR MPH) in Children (6-12 Years) With Attention Deficit Hyperactivity D
Brief Summary: The purpose of this study is to determine the effectiveness and safety of OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.
Detailed Summary:
Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate release methylphenidate has limitations related to its time course of action.As the morning dose wears off, inattention may increase during late-morning classes. Similarly, when the midday dose is wearing off, the child may experience difficulty concentrating on homework. The second problem relates to compliance with midday and late afternoon dosing. Children feel stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses as a result. In other cases, a school nurse may not be available or policies prohibit staff from administering drugs so children may be required to self-administer drug. CONCERTA® was developed to overcome these limitations. The purpose of this study is to see how effective and safe Concerta* is vs. immediate release methylphenidate in children with ADHD.
Patients will take either Concerta* (18, 27, 36, or 54 mg) or Immediate Release Methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.
Sponsor: Janssen-Ortho Inc., Canada
Current Primary Outcome: Change in average SNAP-IV(Swanson, Nolan and Pelham -IV) score from baseline at end of study and the remission of symptoms between groups, defined as an average SNAP-IV score of <=1 at end of study
Original Primary Outcome: Same as current
Current Secondary Outcome: changes at end of study for Parenting Stress Index, Conners Parent Rating Scale, IOWA Conners Parent Rating Scale, Visual Analogue Scale for homework and social play, Resource Use Questionnaire, parent satisfaction, Clinical Global Impression
Original Secondary Outcome: Same as current
Information By: Janssen-Ortho Inc., Canada
Dates:
Date Received: March 17, 2006
Date Started:
Date Completion:
Last Updated: May 16, 2011
Last Verified: April 2010
