Comparison of the Efficacy of Two Different Modified Release Methylphenidate Preparations for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a Natural Setting: Comparison of the Efficacy of Medikinet((R)) Retard and Concerta((R))-a Randomized, Controlled, Double-Blind Multicenter Clinical Crossover Trial.
Author(s): Dopfner M, Ose C, Fischer R, Ammer R, Scherag A
Affiliation(s): 1 Department of Child and Adolescent Psychiatry and Psychotherapy, University of Cologne , Cologne, Germany .
Publication date & source: 2011-10, J Child Adolesc Psychopharmacol., 21(5):445-54. Epub 2011 Jul 26.
Abstract Objective: The comparison of the efficacy of Medikinet((R)) retard and Concerta((R)) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years). The duration of the study per patient was 3 weeks. Methods: The primary outcome variable was the German version of the "Swanson, Kotkin, Agler, M-Flynn, and Pelham scale" in the first 3 hours of school as assessed by teachers. Results: Medikinet retard with a higher IR component than Concerta (and an equivalent daily dose) was superior to Concerta (p=0.0009), and Medikinet retard with similar IR components in the morning as Concerta (but a lower daily dose) was noninferior to Concerta with regard to the primary outcome. Further, exploratory analyses on teacher and parent ratings on attention-deficit/hyperactivity disorder and on externalizing symptoms during the day revealed no evidence for the superiority of Concerta over Medikinet retard in an equivalent daily dosage throughout the day. Conclusion: Children and adolescents may be treated with a lower daily dose of Medikinet retard (which has a similar IR component as Concerta) without resulting in a clinically relevant worse effect during school time.