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A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD

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Abstract.

Objective:

The aim of this study was to study treatment response to atomoxetine in a large, multicenter study of non-North American patients with ADHD.

Methods:

A total of 604 children and adolescents with ADHD were enrolled in a 10-week open-label trial with atomoxetine prior to randomization to a double-blind relapse prevention phase at 33 sites in the United Kingdom, continental Europe, Israel, South Africa, and Australia. All patients had ADHD symptom severity at least 1.5 standard deviations above United States age and gender norms for their diagnostic subtype as measured by the investigator-scored ADHD Rating Scale (ADHD RS). Outcomes were assessed by analysis of change in the ADHD RS; functional and psychosocial outcomes were assessed using the Child Health Questionnaire (CHQ).

Results:

At endpoint, ADHD RS total scores decreased by an average of 56.7%, and 69% of patients were rated as having no or minimal symptoms. Significant improvement was observed in psychosocial and functional outcomes. Discontinuations attributed to adverse events were < 4%.

Conclusion:

These open-label data, gathered in an international setting, add to our knowledge of the value of atomoxetine in treating ADHD symptoms, as well as its safety and tolerability.

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Author information

Authors and Affiliations

  1. Department of Psychiatry, University Medical Center Nijmegen, 9101, 6500, HB Nijmegen, The Netherlands

    Jan K. Buitelaar M. D., Ph. D.

  2. Dienst Kinderpsychiatrie, UZ Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium

    Marina Danckaerts

  3. Dept. of Child and Adolescent Psychiatry, University of Goteborg, Kungsgatan 12, 41119, Göteborg, Sweden

    Christopher Gillberg & Mats Johnson

  4. Child NeuroPsychiatry, Department of Neuroscience, University of Cagliari, Via Ospedale 119, 09124, Cagliari, Italy

    Alessandro Zuddas

  5. Central Institut for Mental Health, Dept. of Child and Adolescent Psychiatry, J5, 68072, Mannheim, Germany

    Katja Becker

  6. Centre Hospitalier Charles Perrens, Service de Psychiatrie de l’Enfant et de l’Adolescent, 121 Rue De La Bechade, Bordeaux Cedex, 33076, France

    Manuel Bouvard

  7. Department of Child Psychiatry, US Medical School, Francie van Zijl drive Parow, 7500, Capetown, South Africa

    Jenny Fagan

  8. Alapitvany a “Gyermek lelki egeszsegeert”, Vadaskert Korhaz es Szakambulancia, Huvosvolgyi ut 116, 1021, Budapest, Hungary

    Julia Gadoros

  9. Ryegate Children’s Centre Tapton, Crescent Road, Sheffield, S10 5DD, England

    Valerie Harpin

  10. Child & Youth Mental Health Service, Wallsend Hospital, Longworth Road, Wallsend NSW 2287, Australia

    Philip Hazell

  11. Pediatric Neurology Unit, E. Wolfson Medical Center, Holon, 58100, Israel

    Tally Lerman-Sagie

  12. Dept. of Psychiatry & Medical Psychology, University of Navarra, 31008, Pamplona, Spain

    Cesar A. Soutullo

  13. Dpto.Klinika Psychiatrii Dzieciecej, AM w Warszawie, ul. Marszalkowska 24, 00-576, Warszawa, Poland

    Tomasz Wolanczyk

  14. Senter for barne—og ungdomspsykiatri, Sognsvannsveien 53/67, 26, 0319, Oslo, Norway

    Pal Zeiner

  15. Lilly Research Laboratories, Indianapolis, Indiana, 46285, USA

    Daniel S. Fouche, Judith Krikke-Workel, Shuyu Zhang & David Michelson

  16. Department of Psychiatry & Academic Center for Child and Adolescent Psychiatry, University Medical Center St. Radbond (Internal Post 333), 6500, HB Nijmegen, The Netherlands

    Jan K. Buitelaar M. D., Ph. D.

Authors
  1. Jan K. Buitelaar M. D., Ph. D.
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  2. Marina Danckaerts
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  3. Christopher Gillberg
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  5. Katja Becker
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  6. Manuel Bouvard
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  7. Jenny Fagan
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  8. Julia Gadoros
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  9. Valerie Harpin
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  10. Philip Hazell
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  11. Mats Johnson
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  12. Tally Lerman-Sagie
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  13. Cesar A. Soutullo
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  14. Tomasz Wolanczyk
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  15. Pal Zeiner
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  16. Daniel S. Fouche
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  17. Judith Krikke-Workel
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  18. Shuyu Zhang
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  19. David Michelson
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Buitelaar, J.K., Danckaerts, M., Gillberg, C. et al. A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD. European Child & Adolescent Psychiatry 13, 249–257 (2004). https://doi.org/10.1007/s00787-004-0401-3

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  • DOI: https://doi.org/10.1007/s00787-004-0401-3

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