Ml. Wolraich et al., Randomized, controlled trial of OROS methylphenidate once a day in children with attention-deficit/hyperactivity disorder, PEDIATRICS, 108(4), 2001, pp. 883-892
Objective. A new once-a-day methylphenidate (MPH) formulation, Concerta (me
thylphenidate HCl) extended-release tablets (OROS MPH), has been developed.
This study was conducted to determine the safety and efficacy of OROS MPH
in a multicenter, randomized, clinical trial.
Methods. Children with attention-deficit/hyperactivity disorder (ADHD; n =
282), all subtypes, ages 6 to 12 years, were randomized to placebo (n = 90)
, immediate-release methylphenidate (IR MPH) 3 times a day (tid; dosed ever
y 4 hours; n = 97), or OROS MPH once a day (qd; n = 95) in a double-blind,
28-day trial. Outcomes in multiple domains were assessed, and data were ana
lyzed using analysis of variance and Kaplan Meier product limit estimates f
or time to study cessation. The primary time point for analysis was the las
t available patient visit using last observation carried forward.
Results. Children in the OROS and IR MPH groups showed significantly greate
r reductions in core ADHD symptoms than did children on placebo. This was t
rue both at the end of week 1 and at the end of treatment on the basis of m
ean teacher and parent IOWA Conners ratings. IR MPH tid and OROS MPH qd did
not differ significantly on any direct comparisons. Forty-eight percent of
the placebo group discontinued early compared with 14% and 16% in the IR M
PH and OROS MPH groups, respectively.
Conclusions. For the treatment of core ADHD symptoms, OROS MPH dosed qd and
IR MPH dosed tid were superior to placebo and were not significantly diffe
rent from each other.