Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder.

Joseph Biederman, John H. Heiligenstein, Douglas E. Faries, Nora Galil, Ralf Dittmann, Graham J. Emslie, Christopher J. Kratochvil, Harry F. Laws, Kory J. Schuh

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)e75
JournalPediatrics
Volume110
Issue number6
DOIs
StatePublished - Dec 2002

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Attention Deficit Disorder with Hyperactivity
Placebos
Research Personnel
Neurotransmitter Transport Proteins
Norepinephrine Plasma Membrane Transport Proteins
Neurotransmitter Receptor
Atomoxetine Hydrochloride
Random Allocation
Diagnostic and Statistical Manual of Mental Disorders
Clinical Trials

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Biederman, J., Heiligenstein, J. H., Faries, D. E., Galil, N., Dittmann, R., Emslie, G. J., ... Schuh, K. J. (2002). Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. Pediatrics, 110(6), e75. https://doi.org/10.1542/peds.110.6.e75

Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. / Biederman, Joseph; Heiligenstein, John H.; Faries, Douglas E.; Galil, Nora; Dittmann, Ralf; Emslie, Graham J.; Kratochvil, Christopher J.; Laws, Harry F.; Schuh, Kory J.

In: Pediatrics, Vol. 110, No. 6, 12.2002, p. e75.

Research output: Contribution to journalArticle

Biederman, J, Heiligenstein, JH, Faries, DE, Galil, N, Dittmann, R, Emslie, GJ, Kratochvil, CJ, Laws, HF & Schuh, KJ 2002, 'Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder.', Pediatrics, vol. 110, no. 6, pp. e75. https://doi.org/10.1542/peds.110.6.e75
Biederman J, Heiligenstein JH, Faries DE, Galil N, Dittmann R, Emslie GJ et al. Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. Pediatrics. 2002 Dec;110(6):e75. https://doi.org/10.1542/peds.110.6.e75
Biederman, Joseph ; Heiligenstein, John H. ; Faries, Douglas E. ; Galil, Nora ; Dittmann, Ralf ; Emslie, Graham J. ; Kratochvil, Christopher J. ; Laws, Harry F. ; Schuh, Kory J. / Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. In: Pediatrics. 2002 ; Vol. 110, No. 6. pp. e75.
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