OBJECTIVE: The aim of this study was to compare efficacy and safety of two long-acting formulations of methylphenidate (MPH) for attention-deficit/hyperactivity disorder (ADHD) in school-age children. METHODS:Children 6-12 years of age diagnosed with ADHD and stabilized on MPH (20-40 mg/day) participated in a five-way, randomized, placebo-controlled, single-blind, crossover study conducted in a laboratory classroom setting. Children alternately received single doses of extended-release MPH (ER-MPH) 20 and 40 mg, modified-release MPH (OROS-MPH) 18 and 36 mg, and placebo over 6 consecutive weeks. Efficacy was assessed using SKAMP rating subscales and written math tests. Data were examined using between-treatment comparisons of area under the curve (AUC) for change from predose values during hours 0-4, 0-8, 8-12, and 0-12. Safety was assessed. RESULTS:Fifty-three children completed the study. For all efficacy measures, improvements from predose were significantly greater with ER-MPH 40 mg than with OROS-MPH 36 mg in terms of AUC(0-4) (p < or = 0.005), AUC(0-8) (p < or = 0.006), and AUC(0-12) (p < or = 0.035). For most measures, ER-MPH 20 mg was equivalent to both doses of OROS-MPH in AUC(0-4), AUC(0-8), and AUC(0-12). No serious adverse events were reported. CONCLUSIONS: The efficacy of ER-MPH 20 mg is similar to that of OROS-MPH 18 and 36 mg during the first 8 hours postdose. Statistically greater benefits are observed with ER-MPH 40 mg than with OROS-MPH 36 mg and persist through hour 8. Active treatments show comparable efficacy from 8 to 12 hours postdose. Both doses of each MPH formulation are well tolerated.
RCT Entities:
OBJECTIVE: The aim of this study was to compare efficacy and safety of two long-acting formulations of methylphenidate (MPH) for attention-deficit/hyperactivity disorder (ADHD) in school-age children. METHODS:Children 6-12 years of age diagnosed with ADHD and stabilized on MPH (20-40 mg/day) participated in a five-way, randomized, placebo-controlled, single-blind, crossover study conducted in a laboratory classroom setting. Children alternately received single doses of extended-release MPH (ER-MPH) 20 and 40 mg, modified-release MPH (OROS-MPH) 18 and 36 mg, and placebo over 6 consecutive weeks. Efficacy was assessed using SKAMP rating subscales and written math tests. Data were examined using between-treatment comparisons of area under the curve (AUC) for change from predose values during hours 0-4, 0-8, 8-12, and 0-12. Safety was assessed. RESULTS: Fifty-three children completed the study. For all efficacy measures, improvements from predose were significantly greater with ER-MPH 40 mg than with OROS-MPH 36 mg in terms of AUC(0-4) (p < or = 0.005), AUC(0-8) (p < or = 0.006), and AUC(0-12) (p < or = 0.035). For most measures, ER-MPH 20 mg was equivalent to both doses of OROS-MPH in AUC(0-4), AUC(0-8), and AUC(0-12). No serious adverse events were reported. CONCLUSIONS: The efficacy of ER-MPH 20 mg is similar to that of OROS-MPH 18 and 36 mg during the first 8 hours postdose. Statistically greater benefits are observed with ER-MPH 40 mg than with OROS-MPH 36 mg and persist through hour 8. Active treatments show comparable efficacy from 8 to 12 hours postdose. Both doses of each MPH formulation are well tolerated.
Authors: Matthew Brams; Rafael Muniz; Ann Childress; John Giblin; Alice Mao; John Turnbow; Mary Borrello; Kevin McCague; Frank A Lopez; Raul Silva Journal: CNS Drugs Date: 2008 Impact factor: 5.749
Authors: Ole Jakob Storebø; Erica Ramstad; Helle B Krogh; Trine Danvad Nilausen; Maria Skoog; Mathilde Holmskov; Susanne Rosendal; Camilla Groth; Frederik L Magnusson; Carlos R Moreira-Maia; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Bente Forsbøl; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2015-11-25