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Efficacy of a New Pattern of Delivery of Methylphenidate for the Treatment of ADHD: Effects on Activity Level in the Classroom and on the Playground

https://doi.org/10.1097/00004583-200211000-00011Get rights and content

ABSTRACT

Objective:

To evaluate the pharmacodynamic effects of an experimental (EXP) delivery of methylphenidate (MPH) in children with attention-deficit/hyperactivity disorder and to investigate the situational nature of effects in laboratory classroom and playground settings.

Method:

A “sipping” study methodology was used to deliver a bolus followed by small but increasing MPH doses as the EXP regimen. A randomized, double-blind crossover design was used to compare the EXP regimen to a thrice-daily (TID) regimen and a placebo (PLA) regimen. Measures of efficacy were obtained from a Motionlogger® actigraph to quantify activity and from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale to quantify two domains of behavior (attention and deportment).

Results:

Compared with PLA, both EXP and TID delivery of MPH produced large, significant reductions in activity and inappropriate behavior in the classroom, but the two MPH regimens did not differ in onset or duration of effects across the day. The MPH effects were situationally dependent and were smaller for the playground than for the classroom settings.

Conclusions:

The findings of this “proof of concept” study support the efficacy of a continuous, ascending delivery of MPH. The situational effects of MPH provide support for the theory of selective effects of stimulants, dependent on the demands of the environment.

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In the treatment of children with attention-deficit/hyperactivity disorder (ADHD), methylphenidate (MPH) is prescribed to reduce inappropriately high and impairing levels of activity, inattention, and impulsivity in the classroom. But there has been concern that the clinical use of MPH may reduce

METHOD

The detailed methods for this study are described in a report that presents the analyses of the primary outcome measures (Swanson et al., in press). Briefly, children aged 7–12 years, who met DSM-IV criteria for a diagnosis of ADHD and were taking 5 to 15 mg of MPH administered BID or TID, participated in this “proof of concept” study, providing they had normal blood pressure, were not physically ill, and were able to understand that they could withdraw from the study at any time. Children with

RESULTS

Thirty-two children (28 boys and 4 girls; aged 7–12 years, mean age 9.9 years), who met DSM-IV criteria for a diagnosis of ADHD (30 with combined type; 2 with hyperactivity/impulsivity) were enrolled. Upon entry, these subjects were being treated with 5–15 mg of MPH administered BID or TID, with a mean initial MPH dose of 11.6 mg (0.4 mg/kg per day) and a mean absolute daily dose of 28.9 mg (0.9 mg/kg per day). Based on prestudy dosage, each subject was assigned to the low (n = 7), intermediate

DISCUSSION

In the analyses of secondary outcome measures from this “proof of concept” study, we evaluated the effects of two patterns of MPH delivery (EXP and TID), and we found that these two medication conditions produced equal improvements across all three domains (activity, attention, deportment). This finding supports the conceptual framework (based on acute tolerance) for the application of an osmotically driven continuous delivery system (OROS) for a once-a-day dosing formulation of MPH (Concerta).

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    Supported by the ALZA Corporation, Mountain View, CA.

    Correspondence to Dr. Swanson, Department of Pediatrics, Child Development Center, 19722 MacArthur Blvd., Irvine, CA 92612.

    DOI: 10.1097/01.CHI.0000024841.60748.54

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