PEDIATRICS Vol. 108 No. 4 October 2001, pp. 883-892
Randomized, Controlled Trial of OROS Methylphenidate Once a Day in Children With Attention-Deficit/Hyperactivity Disorder
Received Jun 5, 2000; accepted Mar 2, 2001.
,
,,
From * Vanderbilt University, Nashville, Tennessee; Objective. A new once-a-day
methylphenidate (MPH) formulation, Concerta (methylphenidate 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
every 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 analyzed using analysis of variance and Kaplan Meier product limit estimates for time
to study cessation. The primary time point for analysis was the last
available patient visit using last observation carried forward.
Results. Children in the OROS and IR MPH groups showed
significantly greater reductions in core ADHD symptoms than did
children on placebo. This was true both at the end of week 1 and at the
end of treatment on the basis of mean 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 MPH 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 different from each other.attention-deficit/hyperactivity disorder, methylphenidate, OROS,
Concerta.
New York
State Psychiatric Institute, New York; § State University of New York
at Buffalo, Buffalo, New York; University of California at Irvine,
Irvine, California; ¶ Massachusetts General Hospital, Boston,
Massachusetts; # University of Rochester, Rochester, Minnesota;
** University of Illinois at Chicago, Chicago, Illinois;
University of Chicago, Chicago, Illinois; §§ Western Psychiatric
Institute and Clinic, University of Pittsburgh, Pittsburgh,
Pennsylvania; and || University of Minnesota, Rochester, Minnesota.
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