Efficacy of two long-acting methylphenidate formulations in children with attention- deficit/hyperactivity disorder in a laboratory classroom setting.
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.
Silva
Raul
R
Department of Psychiatry, New York University School of Medicine, New York, New York 10016, USA. raul.silva@med.nyu.edu
Muniz
Rafael
R
Pestreich
Linda K
LK
Brams
Matthew
M
Childress
Ann
A
Lopez
Frank A
FA
D019540:Area Under Curve; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008433:Mathematics; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D018401:Sample Size; D012574:Schools; D016037:Single-Blind Method; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate