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

Jan K. Buitelaar, Marina Danckaerts, Christopher Gillberg, Alessandro Zuddas, Katja Becker, Manuel Bouvard, Jenny Fagan, J. Gádoros, Valerie Harpin, Philip Hazell, Mats Johnson, Tally Lerman-Sagie, Cesar A. Soutullo, Tomasz Wolanczyk, Pal Zeiner, Daniel S. Fouche, Judith Krikke-Workel, Shuyu Zhang, David Michelson

Research output: Contribution to journalArticle

65 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)249-257
Number of pages9
JournalEuropean Child and Adolescent Psychiatry
Volume13
Issue number4
DOIs
Publication statusPublished - Aug 2004

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South Australia
Israel
Random Allocation
Secondary Prevention
South Africa
Multicenter Studies
Research Personnel
Safety
Atomoxetine Hydrochloride
Therapeutics
Child Health
Surveys and Questionnaires
United Kingdom

Keywords

  • ADHD
  • Atomoxetine
  • Children
  • European
  • ODD

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD. / Buitelaar, Jan K.; Danckaerts, Marina; Gillberg, Christopher; Zuddas, Alessandro; Becker, Katja; Bouvard, Manuel; Fagan, Jenny; Gádoros, J.; Harpin, Valerie; Hazell, Philip; Johnson, Mats; Lerman-Sagie, Tally; Soutullo, Cesar A.; Wolanczyk, Tomasz; Zeiner, Pal; Fouche, Daniel S.; Krikke-Workel, Judith; Zhang, Shuyu; Michelson, David.

In: European Child and Adolescent Psychiatry, Vol. 13, No. 4, 08.2004, p. 249-257.

Research output: Contribution to journalArticle

Buitelaar, JK, Danckaerts, M, Gillberg, C, Zuddas, A, Becker, K, Bouvard, M, Fagan, J, Gádoros, J, Harpin, V, Hazell, P, Johnson, M, Lerman-Sagie, T, Soutullo, CA, Wolanczyk, T, Zeiner, P, Fouche, DS, Krikke-Workel, J, Zhang, S & Michelson, D 2004, 'A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD', European Child and Adolescent Psychiatry, vol. 13, no. 4, pp. 249-257. https://doi.org/10.1007/s00787-004-0401-3
Buitelaar, Jan K. ; Danckaerts, Marina ; Gillberg, Christopher ; Zuddas, Alessandro ; Becker, Katja ; Bouvard, Manuel ; Fagan, Jenny ; Gádoros, J. ; Harpin, Valerie ; Hazell, Philip ; Johnson, Mats ; Lerman-Sagie, Tally ; Soutullo, Cesar A. ; Wolanczyk, Tomasz ; Zeiner, Pal ; Fouche, Daniel S. ; Krikke-Workel, Judith ; Zhang, Shuyu ; Michelson, David. / A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD. In: European Child and Adolescent Psychiatry. 2004 ; Vol. 13, No. 4. pp. 249-257.
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