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Cited by 378Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesBehavioral and Psychological Studies

Once-a-Day Concerta Methylphenidate Versus Three-Times-Daily Methylphenidate in Laboratory and Natural Settings

Pelham, William E., Gnagy, Elizabeth M., Burrows-Maclean, Lisa, Williams, Andy, Fabiano, Gregory A., Morrisey, Sean M., Chronis, Andrea M., Forehand, Gregory L. +10 more·2001·Pediatrics
DOI 10.1542/peds.107.6.e105
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Abstract

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.

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Authors
Pelham, W. E., Gnagy, E. M., Burrows-Maclean, L., Williams, A., Fabiano, G. A., Morrisey, S. M., Chronis, A. M., Forehand, G. L., Nguyen, C. A., Hoffman, M. T., Lock, T. M., Fielbelkorn, K., Coles, E. K., Panahon, C. J., Steiner, R. L., Meichenbaum, D. L., Onyango, A. N., & Morse, G. D.
Affiliations
  • From the Departments of Psychology,
  • Pediatrics and Genetics (US)
  • University at Buffalo, State University of New York (US)
ORCID
Venue
Pediatrics
Publisher
American Academy of Pediatrics (AAP)
Published
2001-06-01
Volume
107
Issue
6
Pages
e105-e105
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.107.6.e105
OpenAlex
W2148978240
Cited by
378
References
62
Citations by year
2026: 1 · 2025: 5 · 2024: 4 · 2023: 7 · 2022: 5 · 2021: 6 · 2020: 8 · 2019: 4 · 2018: 4 · 2017: 7 · 2016: 9 · 2015: 10 · 2014: 26 · 2013: 16 · 2012: 16
FWCI
11.10
Type
journal article
Language
en
Open access
closed
Locations
  • PEDIATRICS (publishedVersion)
  • PubMed (publishedVersion)
  • Cornerstone (Minnesota State University, Mankato) (submittedVersion)
Funders
  • National Institute on Alcohol Abuse and Alcoholism (AA 11873)
  • National Institute of Mental Health (U01MH050467, MH-50467, R01MH053554, MH-53554)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
Keywords
methylphenidate, Concerta, sustained-release formulation, attention deficit hyperactivity disorder, children, dosing frequency, duration of action, medication adherence, behavioral parent training, classroom behavior, academic performance, naturalistic settings, laboratory setting, stimulant medication, dose equivalence, teacher ratings, parent ratings, summer treatment program
MeSH terms
Analysis of Variance, Attention Deficit Disorder with Hyperactivity, Behavior Therapy, Child, Delayed-Action Preparations, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Placebos, Treatment Outcome, Cross-Over Studies

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