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Atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: a 6-week, randomized, placebo-controlled, double-blind trial in Russia

European Child & Adolescent Psychiatry volume 19, pages 57–66 (2010)Cite this article

Abstract

The objective of the study was to compare the efficacy and tolerability of once-daily atomoxetine (≤1.8 mg/(kg day) with those of placebo in children and adolescents (aged 6–16 years) with attention-deficit/hyperactivity disorder [ADHD (DSM-IV)]. This randomized, placebo-controlled, double-blind trial was conducted in Russia. The primary efficacy measure was baseline-to-end point changes in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score. Tolerability measures included treatment-emergent signs and symptoms (TESS), laboratory values and weight. Compared with patients in the placebo group (n = 33), patients treated with atomoxetine (n = 72) with a mean final dose of 1.4 mg/kg showed significantly greater improvement in ADHDRS-IV-Parent:Inv total score (least-squares mean: atomoxetine, –15.8; placebo, –11.4; p = 0.013). The most common TESS in the atomoxetine group included anorexia [atomoxetine, n = 13 (18.1%); placebo, n = 2 (6.1%)], somnolence, n = 11 versus n = 3 (15.3% vs. 9.1%, respectively), abdominal pain n = 9 versus n = 1 (12.5% vs. 3.0%, respectively) and nausea, n = 8 versus n = 1 (11.1% vs. 3.0%, respectively). Seven patients in the atomoxetine group and two in the placebo group experienced clinically important weight loss during the study (≥7% from baseline; mean change, kg: atomoxetine, –0.6; placebo, 0.1; p = 0.032). Atomoxetine is efficacious in improving ADHD symptoms in children and adolescents. Atomoxetine treatment may be associated with a numerically higher incidence of anorexia, somnolence, abdominal pain and nausea, as well as statistically greater losses in body weight.

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Acknowledgment

The authors thank Svetlana Dominguez for helping to prepare this paper.

Financial disclosure

Drs. Martenyi and Jarkova are employees and stockholders of Eli Lilly and Company. Dr. Zavadenko is a member of the Lilly ADHD advisory board. The rest of the authors do not have any financial disclosures to report. This study was funded by Eli Lilly and Company.

Author information

Affiliations

  1. Lilly Corporate Center, Lilly Research Laboratories, Indianapolis, IN, 46285, USA

    Ferenc Martenyi

  2. Russian State Medical University, Moscow, Russia

    Nikolay N. Zavadenko, Leonid M. Bardenstein & Andrey S. Petrukhin

  3. Eli Lilly Vostok S.A., Moscow, Russia

    Natalia B. Jarkova

  4. InnoPharm Ltd., Smolensk, Russia

    Alexandr A. Yarosh & Victoria O. Soldatenkova

  5. Mental Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia

    Irina A. Kozlova

  6. Bekhterev Psychoneurology Scientific and Research Institute, St. Petersburg, Russia

    Nikolay G. Neznanov

  7. Child Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia

    Olga I. Maslova

  8. Scientific and Research Institute of Psychiatry, Moscow, Russia

    Nina K. Sukchotina

  9. Russian Medical Academy of Postgraduate Education, Moscow, Russia

    Valeriy P. Zykov

Authors
  1. Ferenc Martenyi
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  2. Nikolay N. Zavadenko
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  3. Natalia B. Jarkova
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  4. Alexandr A. Yarosh
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  5. Victoria O. Soldatenkova
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  6. Leonid M. Bardenstein
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  7. Irina A. Kozlova
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  8. Nikolay G. Neznanov
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  9. Olga I. Maslova
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  10. Andrey S. Petrukhin
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  11. Nina K. Sukchotina
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  12. Valeriy P. Zykov
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Corresponding author

Correspondence to Ferenc Martenyi.

Additional information

Clinical Trials Registry: NCT00386581, http://www.clinicaltrials.gov/.

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Martenyi, F., Zavadenko, N.N., Jarkova, N.B. et al. Atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: a 6-week, randomized, placebo-controlled, double-blind trial in Russia. Eur Child Adolesc Psychiatry 19, 57–66 (2010). https://doi.org/10.1007/s00787-009-0042-7

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  • DOI: https://doi.org/10.1007/s00787-009-0042-7

Keywords

  • Atomoxetine
  • ADHD
  • Nonstimulant
  • Children
  • Once daily