title: A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).
abstract: OBJECTIVE
  Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®).
  
  
  METHODS
  Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II).
  
  
  RESULTS
  Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study.
  
  
  CONCLUSIONS
  Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.
authors.affiliation: Clinique Woodward, 717, rue Woodward, DIEX Research Inc., Sherbrooke, QC, J1G 1W4, Canada.
authors.forename: Angelo
authors.initials: A
authors.lastname: Fallu
authors.affiliation: FB2D Clinical Research Consulting, Montréal, Québec, Canada.
authors.forename: Farida
authors.initials: F
authors.lastname: Dabouz
authors.affiliation: START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada.
authors.forename: Melissa
authors.initials: M
authors.lastname: Furtado
authors.affiliation: START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada.
authors.forename: Leena
authors.initials: L
authors.lastname: Anand
authors.affiliation: START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada.
authors.forename: Martin A
authors.initials: MA
authors.lastname: Katzman
keywords: CONCERTA®; attention-deficit/hyperactivity disorder; bioequivalence; generic; novo-methylphenidate