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A Laboratory School Comparison of Mixed Amphetamine Salts Extended Release (Adderall XR®) and Atomoxetine (Strattera®) in School-Aged Children With Attention Deficit/Hyperactivity Disorder

University of California, Irvine, sbwigal{at}uci.edu

James J. McGough

University of California, Los Angeles

James T. McCracken

University of California, Los Angeles

Joseph Biederman

Harvard University and Massachusetts General Hospital, Boston

Thomas J. Spencer

Harvard University and Massachusetts General Hospital, Boston

Kelly L. Posner

Columbia University Medical Center

Tim L. Wigal

University of California, Irvine

Scott H. Kollins

Duke University Medical School

Tanya M. Clark

Shire Pharmaceuticals, Inc., on behalf of the SLI381.404 Study Group

David A. Mays

Shire Pharmaceuticals, Inc., on behalf of the SLI381.404 Study Group

Yuxin Zhang

Shire Pharmaceuticals, Inc., on behalf of the SLI381.404 Study Group

Simon J. Tulloch

Shire Pharmaceuticals, Inc., on behalf of the SLI381.404 Study Group

Mixed amphetamine salts extended release (MAS XR; Adderall XR^®) and atomoxetine (Strattera^®) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder (ADHD) combined or hyperactive/impulsive type in a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study. Primary efficacy measure was the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) behavioral rating scale. Changes in mean SKAMP deportment scores from baseline were significantly greater for MAS XR (n = 102) than for atomoxetine (n = 101) overall (-0.56 and -0.13, respectively; p < .0001) and at each week (p < .001). Adverse events were similar for both treatment groups. The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than atomoxetine in children with ADHD.

Key Words: attention deficit/hyperactivity disorder • ADHD • Adderall • Strattera • Atomoxetine • mixed amphetamine salts

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