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Comparison of the Efficacy of Two Different Modified Release Methylphenidate Preparations for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a Natural Setting

Objective: The comparison of the efficacy of Medikinet retard and Concerta trial was a multisite, randomized, doubleblind, 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.

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