Comparative Efficacy of Two Once Daily Methylphenidate Formulations (Ritalin?? LA???1 and Concerta??) and Placebo in Children with Attention Deficit Hyperactivity Disorder Across the School Day (original) (raw)

Ritalin ® LA™ (20mg) to the starting dose of Concerta ® (18mg), in a laboratory school setting for the duration of an entire school day. Secondary objectives were to compare Ritalin ® LA™ 20mg with Concerta ® 36mg, and Ritalin ® LA™ and both Concerta ® doses versus placebo across the school day. Methods: Thirty-six children (29 males, 7 females), aged 6-12 years, with attention deficit hyperactivity disorder, previously stabilized on methylphenidate (MPH), completed this four-way, randomized, single-blind crossover, analog classroom study. Patients were evaluated on day 0 and randomized to receive treatment on days 7, 14, 21, and 28 (Ritalin ® LA™ 20mg, Concerta ® 18mg, Concerta ® 36mg, or placebo). Results: Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale (SKAMP)-attention: The effect of Ritalin ® LA™ 20mg across the morning was statistically different from that of Concerta 18mg and 36mg, as demonstrated by the change in the area under the curve (AUC) during the first 4 hours (0-4) from pre-dose. AUC(0-4) for Ritalin ® LA™ was-2.48 versus-1.36 for Concerta ® 18mg (p = 0.015), and-1.55 for Concerta ® 36mg (p = 0.043). AUC(0-8) change from pre-dose for Ritalin ® LA™ was-4.48 versus-2.72 for Concerta ® 18mg (p = 0.074), and-3.24 for Concerta ® 36mg (p = 0.208). SKAMP-deportment: AUC(0-4) for Ritalin ® LA™ was-1.67 compared with-0.28 for Concerta ® 18mg (p < 0.001), and-0.55 for Concerta ® 36mg (p = 0.004). AUC(0-8) change from pre-dose for Ritalin ® LA™ was-2.81 compared with-0.82 for Concerta ® 18mg (p = 0.018), and-1.34 for Concerta ® 36mg (p = 0.078). Combined: Mean AUC(0-4) change from pre-dose for Ritalin ® LA™ was-2.05 compared with-0.78 for Concerta ® 18mg (p < 0.001),-1.01 for Concerta ® 36mg (p = 0.003). The mean AUC(0-8) change from pre-dose for Ritalin ® LA™ was-3.58 compared with-1.70 for Concerta ® 18mg (p = 0.010),-2.22 for Concerta ® 36mg (p = 0.061). Math test-attempted: Mean pre-dose score for Ritalin ® LA™ was about 73 compared with 74, 90, and 81 for Concerta ® 18mg, 36mg, and placebo, respectively. Mean AUC(0-8) change from pre-dose for Ritalin ® LA™ was 202 compared with 115 for Concerta ® 18mg (p = 0.135), 137 for Concerta ® 36mg (p = 0.265). Math test-correct: Mean pre-dose score for Ritalin ® LA™ was 68 compared with 64, 78, and 76 for Concerta ® 18mg, 36mg, and placebo, respectively. Mean AUC(0-8) change from pre-dose for Ritalin ® LA™ was 183 compared with 100 for Concerta ® 18mg (p = 0.144), and 117 for Concerta ® 36mg (p = 0.245). 1 The use of tradenames is for product identification purposes only and does not imply endorsement.