A Double-Blind, Randomized, Placebo/Active Controlled Crossover Evaluation of the Efficacy and Safety of Ritalin (R) LA in Children with Attention-Deficit/Hyperactivity Disorder in a Laboratory Classroom Setting

作者：Schulz Eberhard^*; Fleischhaker Christian; Hennighausen Klaus; Heiser Philip; Oehler Klaus Uwe; Linder Martin; Haessler Frank; Huss Michael; Warnke Andreas; Schmidt Martin; Schulte Markworth Michael; Sieder Christian; Klatt Jan; Tracik Ferenc

来源：Journal of Child and Adolescent Psychopharmacology, 2010, 20(5): 377-385.

DOI：10.1089/cap.2009.0106

Objectives: The primary objective of this study was to demonstrate efficacy of Ritalin (R) LA 20 mg by showing superiority to placebo and noninferiority to Medikinet (R) Retard in a laboratory classroom setting. Secondary objectives included safety/tolerability and further efficacy parameters.
Methods: A total of 147 children with attention-deficit/hyperactivity disorder (ADHD) diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) and aged 6-14 (81% males) and known to be methylphenidate (MPH) responders were enrolled in this multicenter, double-blind, randomized, placebo/active-controlled, three-period (7 days each) crossover study. The Swanson, Kotlin, Agler, M-Flynn, and Pelham (SKAMP) scale was used for efficacy ratings. The mean of SKAMP Combined ratings performed at 10: 30 a. m., at 12: 00 a. m., and at 1: 30 p. m. was defined as the primary parameter.
Results: In all, 146 patients completed all treatment periods. Intensity and frequency of adverse events were comparable between the two formulations. Ritalin (R) LA demonstrated superiority compared to placebo (p< 0.0001). The observed difference in the SKAMP scores between Ritalin (R) LA and Medikinet (R) Retard between the hours 1.5 until 4.5 did not exceed the noninferiority margin (p 0.0003); therefore, the difference is regarded as not clinically relevant. Similar results were obtained for the secondary efficacy variables.
Conclusion: Ritalin (R) LA is an efficacious, well-tolerated treatment option for children aged 6-14 with ADHD.

• 出版日期2010-10
• 单位上海市精神卫生中心