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PEDIATRICS Vol. 110 No. 6 December 2002, pp. e75

ELECTRONIC ARTICLE

Efficacy of Atomoxetine Versus Placebo in School-Age Girls With Attention-Deficit/Hyperactivity Disorder

Joseph Biederman, MD*, John H. Heiligenstein, MD{ddagger}, Douglas E. Faries, PhD{ddagger}, Nora Galil, MD§, Ralf Dittmann, MD, PhD||, Graham J. Emslie, MD, Christopher J. Kratochvil, MD#, Harry F. Laws, MD{ddagger} and Kory J. Schuh, PhD{ddagger} Atomoxetine ADHD Study Group

* Massachusetts General Hospital, Boston, Massachusetts
{ddagger} Lilly Research Laboratories, Indianapolis, Indiana
§ Neuroscience Inc, Bethesda, Maryland
|| Lilly Deutschland GmbH, Bad Homburg, and Psychosomatic Department, Children’s Hospital, University of Hamburg, Hamburg, Germany
University of Texas Southwestern Medical Center, Dallas, Texas
# University of Nebraska Medical Center, Omaha, Nebraska

--> Objective. The efficacy of atomoxetine was assessed in school-age girls with attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors.

Methods. A total of 291 children who were 7 to 13 years of age and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD participated in 1 of 2 combined, double-blind, placebo-controlled, multisite, identical clinical trials. This intent-to-treat subset analysis examined the effects of atomoxetine versus placebo in 51 girls who were randomized to atomoxetine (n = 30) or placebo (n = 21) for 9 weeks. ADHD symptoms were assessed using parent- and investigator-rated scales.

Results. Atomoxetine was superior to placebo on the following measures: the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the Inattentive and Hyperactive/Impulsive subscales of the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the ADHD Index subscale of the Conners’ Parent Rating Scale-Revised: Short Form; and the Clinical Global Impressions of Severity of ADHD. Statistically significant efficacy was seen 1 week after randomization and remained so for the duration of the study. One patient from each of the atomoxetine and placebo groups discontinued the study as a result of an adverse event.

Conclusion. Atomoxetine was found to be effective and well tolerated for the treatment of ADHD in school-age girls.

Key Words: atomoxetine • ADHD • school-age • girls • nonstimulant

Abbreviations: ADHD, attention-deficit/hyperactivity disorder • DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition • ADHD RS, Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score • SD, standard deviation • CPRS-R, Conners’ • Parent Rating Scale-Revised: Short Form • CGI-ADHD-S, Clinical Global Impressions of Severity of ADHD

Received for publication Apr 30, 2002; Accepted Aug 14, 2002.


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