PEDIATRICS Vol. 107 No. 6 June 2001, p. e105
ELECTRONIC ARTICLE:
Once-a-Day Concerta Methylphenidate Versus Three-Times-Daily
Methylphenidate in Laboratory and Natural Settings
Received Dec 11, 2000; accepted Mar 21, 2001.
,,
From the Departments of * Psychology, Objective. Methylphenidate (MPH), the
most commonly prescribed drug for attention-deficit/hyperactivity
disorder (ADHD), has a short half-life, which necessitates multiple
daily doses. The need for multiple doses produces problems with
medication administration during school and after-school hours, and
therefore with compliance. Previous long-acting stimulants and
preparations have shown effects equivalent to twice-daily dosing of
MPH. This study tests the efficacy and duration of action, in natural
and laboratory settings, of an extended-release MPH preparation
designed to last 12 hours and therefore be equivalent to 3-times-daily
dosing.
Methods. Sixty-eight children with ADHD, 6 to 12 years
old, participated in a within-subject, double-blind comparison of
placebo, immediate-release (IR) MPH 3 times a day (tid), and Concerta,
a once-daily MPH formulation. Three dosing levels of medication were
used: 5 mg IR MPH tid/18 mg Concerta once a day (qd); 10 mg IR MPH
tid/36 mg Concerta qd; and 15 mg IR MPH tid/54 mg Concerta qd. All
children were currently medicated with MPH at enrollment, and each
child's dose level was based on that child's MPH dosing before the
study. The doses of Concerta were selected to be comparable to the
daily doses of MPH that each child received. To achieve the ascending
rate of MPH delivery determined by initial investigations to provide the necessary continuous coverage, Concerta doses were 20% higher on a
daily basis than a comparable tid regimen of IR MPH. Children received
each medication condition for 7 days. The investigation was conducted
in the context of a background clinical behavioral intervention in both
the natural environment and the laboratory setting. Parents received
behavioral parent training and teachers were taught to establish a
school-home daily report card (DRC). A DRC is a list of individual
target behaviors that represent a child's most salient areas of
impairment. Teachers set daily goals for each child's impairment
targets, and parents provided rewards at home for goal attainment. Each
weekday, teachers completed the DRC, and it was used as a dependent
measure of individualized medication response. Teachers and parents
also completed weekly standardized ratings of behavior and treatment
effectiveness. To evaluate the time course of medication effects,
children spent 12 hours in a laboratory setting on Saturdays and
medication effects were measured using procedures and methods adapted
from our summer treatment program. Measures of classroom behavior and
academic productivity/accuracy were taken in a laboratory classroom
setting during which children completed independent math and reading
worksheets. Measures of social behavior were taken in structured,
small-group board game settings and unstructured recess settings.
Measures included behavior frequency counts, academic problems
completed and accuracy, independent observations, teacher and counselor ratings, and individualized behavioral target goals. Reports of adverse
events, sleep quality, and appetite were collected.
Results. On virtually all measures in all settings, both
drug conditions were significantly different from placebo, and the 2 drugs were not different from each other. In children's regular school settings, both medications improved behavior as measured by teacher ratings and individualized target behaviors (the DRC); these effects were seen into the evening as measured by parent ratings. In the laboratory setting, effects of Concerta were equivalent to tid MPH and
lasted at least through 12 hours after dosing. Concerta was
significantly superior to tid MPH on 2 parent rating scores, and when
asked, more parents preferred Concerta than preferred tid IR MPH or
placebo. Side effects on children's sleep and appetite were similar
for the 2 preparations. In the lab setting, both medications improved
productivity and accuracy on arithmetic seatwork assignments,
disruptive and on-task behavior, and classroom rule following. Both medications improved children's rule
following and negative behavior in small group board games, as well as
in unstructured recess settings. Individual target behaviors also showed significant improvement with medication across domains in the
laboratory setting. Children's behavior across settings deteriorated
across the laboratory day, and the primary effect of medication was to
prevent this deterioration as the day wore on. Results support the use
of background behavioral treatment in clinical trials of stimulant
medication, and illustrate the utility of a measure of individualized
daily target goals (ie, the DRC) as an objective measure of medication
response in both the laboratory and natural school settings.
Conclusion. This investigation clearly supports the
efficacy of the Concerta long-acting formulation of MPH for parents who
desire to have medication benefits for their child throughout the day
and early evening. Effects of a single morning dose lasted throughout the school day and into the evening hours, and were present for both
social behavior with peers and academic performance in the classroom.
Effects on multiple measures, by multiple informants, and in multiple
settings, were similar to those of a standard preparation of MPH given
3 times a day. These effects lasted throughout a 12-hour period,
providing coverage of school, afternoon, and evening behavior with a
single morning dose. Measures of evening behavior in the laboratory
setting included arithmetic productivity (analogous to homework), and
recess settings (analogous to home and neighborhood recreational
activities). Some parents prefer behavioral interventions to medication
for use at home, and some children with ADHD neither need nor tolerate
medication in the evening. For those who do need a full 12 hours of
medication coverage, based on the results of this study, Concerta would
seem to be the choice. This study provides a model for clinical trials
of new psychoactive drugs for children: assessments by multiple raters, in both natural and ecologically valid laboratory settings, across a
range of domains of impairment and settings, examining a large number
of objective, reliable measures of behavior, and in a context of
ongoing behavioral treatment.
attention-deficit/hyperactivity disorder, pharmacological treatment,
methylphenidate, long-acting preparations.
Pediatrics, and
§ Pharmacy Practice, State University of New York at Buffalo, Buffalo,
New York.
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