Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Contribution
  • Published:
European Child & Adolescent Psychiatry Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Altschuler RA, Maschkovsky MD, Roshchina LF (1973) Sydnocarb is a new stimulant of the central nervous system. Farmacol Toxicol 36:18–23 (in Russian)

    Google Scholar 

  2. Barkley RA, Murrary MB, Edelbrock CS, Robbins K (1990) Side effects of methylphenidate in children with attention-deficit hyperactivity disorder: a systemic, placebo-controlled evaluation. Pediatrics 86:184–192

    CAS  PubMed  Google Scholar 

  3. Bashkatova V, Mathieu-Kia AM, Durand C, Penit-Soria J (2002) Neurochemical changes and neurotoxic effects of an acute treatment with sydnocarb, a novel psychostimulant: comparison with D-amphetamine. Ann N Y Acad Sci 965:180–192

    CAS  PubMed  Google Scholar 

  4. Borinskaya SA, Kozhekbaeva ZhM, Gorbunova EV et al (2004) Analysis of the DRD4 gene polymorphism in populations of Russia and neighboring countries. Russ J Genet 40:679–683 (in Russian)

    Article  CAS  Google Scholar 

  5. Conners CK, Sitarenios G, Parker JD, Epstein JN (1998) The revised Conners’ Parent Rating Scale (CPRS-R): factor structure, reliability, and criterion validity. J Abnorm Child Psychol 26:257–268

    Article  CAS  PubMed  Google Scholar 

  6. Crichton A (1798) An Inquiry into the nature and origin of mental derangement: comprehending a concise system of physiology and pathology of the human mind and history of the passions and their effects. T. Cadell Jr. and W Davies, London (Reprinted by AMS Press, New York, 1976)

  7. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R (1998) ADHD rating scale-IV: checklists, norms, and clinical interpretations. The Guilford Press, New York, NY

    Google Scholar 

  8. Faraone SV (2003) Understanding the effect size of ADHD medication: implications for clinical care. Medscape Psych Ment Health 28:2. www.medscape.com/viewarticle/461543

  9. Faraone SV, Sergeant J, Gillberg C, Biederman J (2003) The worldwide prevalence of ADHD: is it an American condition? World Psychiatry 2:104–113

    PubMed  Google Scholar 

  10. Guy W (1976) ECDEU assessment manual for psychopharmacology, revised. US Department of Health, Education, and Welfare, Bethesda, MD

  11. Ireland W (1877) On idiocy and imbecility. JSA Churchill, London

    Google Scholar 

  12. Kaufman J, Birmaher B, Brent D et al (1997) Schedule for affective disorders and schizophrenia for school-age children present and lifetime version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 136:980–988

    Article  Google Scholar 

  13. Kelsey DK, Sumner CR, Casat CD et al (2004) Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trial. Pediatrics 114:e1–e8

    Article  PubMed  Google Scholar 

  14. Kornilova TV, Grigorenko EL, Smirnov SD (2004) Teenagers of risk groups. Piter Publishers, Moscow-Saint Petersburg, pp 161–333

    Google Scholar 

  15. Krasov VA (1988) Sydnocarb treatment of young schoolchildren with hyperdynamic syndrome. Zh Nevropatol Psikhiatr Im S S Korsakova 88:97–101 (in Russian)

    CAS  PubMed  Google Scholar 

  16. Kratochvil CJ, Wilens TE, Greenhill LL et al (2006) Effects of long-term atomoxetine treatment for young children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 45:919–927

    Article  PubMed  Google Scholar 

  17. Michelson D, Faries D, Wernike J et al (2001) Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose–response study. Pediatrics 108:E83

    Article  CAS  PubMed  Google Scholar 

  18. Michelson D, Allen AJ, Busner J et al (2002) Once-daily atomoxetine treatment for children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry 159:1896–1901

    Article  PubMed  Google Scholar 

  19. Newcorn J, Allen AJ, Sutton V et al (2003) Characteristics of placebo responders in pediatric ADHD clinical trials. Paper presented at the 50th annual meeting of the American academy of child and adolescent psychiatry. Miami, FL

  20. Newcorn HJ, Spencer TJ, Biederman J, Milton DR, Michelson D (2005) Atomoxetine treatment in children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder. J Am Acad Child Adolesc Psychiatry 44:240–248

    Article  PubMed  Google Scholar 

  21. Newcorn HJ, Kratochwill CJ, Allen AJ et al (2008) Atomoxetine and osmotically released methylphenidate for the treatment of attention-deficit hyperactivity disorder: acute comparison and differential response. Am J Psychiatry 165:721–730

    Article  PubMed  Google Scholar 

  22. Palmer ED, Finger S (2001) An early description of ADHD (inattentive subtype): Dr Alexander Crichton and “mental restlessness” (1798). Child Psychol Psychiatry Review 6:66–73

    Google Scholar 

  23. Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA (2007) The worldwide prevalence of ADHD: a systematic review and meta-regression analysis. Am J Psychiatry 164:942–948

    Article  PubMed  Google Scholar 

  24. Still GF (1902) The Culostian lectures on some abnormal psychical conditions in children. Lancet i1008–i1012

  25. Tredgold AF (1908) Mental deficiency (amentia). Tindall and Cox, Bailliere

    Google Scholar 

  26. US Department of Health and Human Services (1995) COSTART: coding symbols of thesaurus of adverse reaction terms, 5th edn. US Food and Drug Administration, Rockville, MD

    Google Scholar 

  27. Uzbekov MG, Misionzhnik EY (2003) Changes in urinary monoamine excretion in hyperkinetic children. Hum Psychopharmacol 18:493–497

    Article  CAS  PubMed  Google Scholar 

  28. Weiss M, Tannock R, Kratochvil C et al (2005) A randomized, placebo-controlled study of once-daily atomoxetine in the school setting in children with ADHD. J Am Acad Child Adolesc Psychiatry 44:647–655

    Article  PubMed  Google Scholar 

  29. Zavadenko N, Suvorinova N (1999) ADHD: study of motor control, attention, memory and experience with nootropics. In: Evrard Ph, Richelme Ch, Tardieu M (eds) Proceedings of the 3rd European paediatric neurology (EPNS) congress, Bologna, Monduzzi Editore, pp 81–85

  30. Zavadenko NN, TIu Uspenskaia, NIu Suvorinova (1997) The diagnosis and treatment of the attention-deficit syndrome in children. Zh Nevropatol Psikhiatr Im S S Korsakova 97(1):57–61

    CAS  Google Scholar 

  31. Zavadenko N, Petrukhin A, Suvorinova N, Grigorieva N (1998) ADHD: study of prevalence, aetiology and efficiency of nootropics therapy. In: Velickovic Perat M (ed) New developments in child neurology. Monduzzi Editore, Bologna, pp 675–679

    Google Scholar 

Download references

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

Authors and 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
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nikolay N. Zavadenko
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Natalia B. Jarkova
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alexandr A. Yarosh
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Victoria O. Soldatenkova
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Leonid M. Bardenstein
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Irina A. Kozlova
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Nikolay G. Neznanov
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Olga I. Maslova
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Andrey S. Petrukhin
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Nina K. Sukchotina
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Valeriy P. Zykov
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ferenc Martenyi.

Additional information

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

Rights and permissions

Reprints and permissions

About this article

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

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

Keywords

Search

Navigation