European Neuropsychopharmacology
Volume 21, Issue 8 , Pages 565-570 , August 2011

The EU paediatric regulation: Effects on paediatric psychopharmacology in Europe

  • Violeta V. Stoyanova-Beninska

      Affiliations

    • Medicines Evaluation Board, The Hague, The Netherlands
    • Corresponding Author InformationCorresponding author. Medicines Evaluation Board, P.O. Box 16229, Kalvermarkt 53, 2500 BE, The Hague, The Netherlands. Tel.: +31 70 3567016.
  • ,
  • Tamar Wohlfarth

      Affiliations

    • Medicines Evaluation Board, The Hague, The Netherlands
  • ,
  • Maria Isaac

      Affiliations

    • European Medicines Agency (EMA), London, United Kingdom
    • Institute of Psychiatry, KCL, London, United Kingdom
  • ,
  • Luuk J. Kalverdijk

      Affiliations

    • Department of Psychiatry, University Medical Centre Groningen, The Netherlands
  • ,
  • Henk van den Berg

      Affiliations

    • Medicines Evaluation Board, The Hague, The Netherlands
    • Emma Children's Hospital, Academic Medical Centre University of Amsterdam, The Netherlands
  • ,
  • Christine Gispen-de Wied

      Affiliations

    • Medicines Evaluation Board, The Hague, The Netherlands
    • Department of Psychiatry, University Medical Centre Utrecht, The Netherlands

Received 15 April 2010 ,Revised 14 June 2010 ,Accepted 19 June 2010.

References 

  1. Arnold LE, Vitiello B, McDougle C, Scahill L, Shah B, Gonzalez NM, et al. Parent-defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials. Journal of the American Academy of Child and Adolescent Psychiatry. 2003;42(12):1443–1450
  2. Ban TA. Pharmacotherapy of mental illness—a historical analysis. Progress in Neuropsychopharmacology & Biological Psychiatry. 2001;25(4):709–727
  3. Bobes J, Arango C, Garcia-Garcia M, Rejas J, CLAMORS Study Collaborative Group . Prevalence of negative symptoms in outpatients with schizophrenia spectrum disorders treated with antipsychotics in routine clinical practice: findings from the CLAMORS study. The Journal of Clinical Psychiatry. 2010;3:280–286Mar 7
  4. Brainstorming sessions 17th ECNP Congress, 2004. http://ecnp.i-site.nl/matters/number8/brainstorm1.shtml Co-opertation FDA EU about pediatric regulation: http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/EuropeanUnion/EuropeanCommission/ucm114342.htm.
  5. Gould MS, Walsh BT, Munfakh JL, Kleinman M, Duan N, Olfson M, et al. Sudden death and use of stimulant medications in youths. The American Journal of Psychiatry. 2009;166(9):992–1001
  6. Hetrick S, Merry S, McKenzie J, Sindahl P, Proctor M. Selective serotonin reuptake inhibitors (SSRIs) for depressive disorders in children and adolescents. 2007;Cochrane Database Syst Rev, Jul 18, 3, CD004851. http://www.dsm5.org/ProposedRevisions/Pages/InfancyChildhoodAdolescence.aspx http://www.ema.europa.eu/htms/human/paediatrics/introduction.htm http://www.ema.europa.eu/pdfs/human/paediatrics/24883409en.pdf http://www.ema.europa.eu/htms/human/paediatrics/decisions.htm
  7. Jadad AR, Booker L, Gauld M, Kakuma R, Boyle M, Cunningham CE, et al. The treatment of attention-deficit hyperactivity disorder: an annotated bibliography and critical appraisal of published systematic reviews and metaanalyses. Canadian Journal of Psychiatry Revue Canadienne De Psychiatrie. 1999;44(10):1025–1035
  8. Kalverdijk LJ, Tobi H, van den Berg PB, Buiskool J, Wagenaar L, Minderaa RB, et al. Use of antipsychotic drugs among Dutch youths between 1997 and 2005. Psychiatric Services. 2008;59:554–560
  9. Koelch M, Schnoor K, Fegert JM. Ethical issues in psychopharmacology of children and adolescents. Current Opinion in Psychiatry. 2008;21(6):598–605
  10. Libby AM, Brent DA, Morrato EH, Orton HD, Allen R, Valuck RJ. Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs. The American Journal of Psychiatry. 2007;164:884–891
  11. McCunne S, Mathis L, Cochetto D, Ball S, Rodriguez W. More appropriate clinical trial design for drug labels. Drug Information Journal. 2006;40:185–195
  12. Moreno C, Laje G, Blanco C, Jiang H, Schmidt AB, Olfson M. National trends in the outpatient diagnosis and treatment of bipolar disorder in youth. Archives of General Psychiatry. 2007;64:1032–1039
  13. Murray ML, Wong IC, de Vries CS. Treating major depression in children and adolescents: research is needed into safer and more effective drugs. BMJ. 2004;328(7438):524–525
  14. Murray ML, Wong IC, Thompson M. Do selective serotonin reuptake inhibitors cause suicide? Antidepressant prescribing to children and adolescents by GPs has fallen since CSM advice. BMJ. 2005;330(7500):1151;May 14
  15. Musto DF. Prevailing and shifting paradigms: a historical perspective. In:  Martin A,  Volkmar FR,  Lewis M editor. Lewis's Child and Adolescent Psychiatry. A Comprehensive Textbook. 4th edition. Philadelphia: Lippincott, Williams and Wilkins; 2007;
  16. Pediatric Labeling Changes through February 24, 2010. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
  17. Rapado-Castro M, Soutullo C, Fraguas D, Arango C, Payá B, Castro-Fornieles J, et al. Predominance of symptoms over time in early-onset psychosis: a principal component factor analysis of the Positive and Negative Syndrome Scale. The Journal of Clinical Psychiatry. 2010;71(3):327–337Mar
  18. Rice, C. Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, United States, 2006. 2009, Surveillance Summaries December 18, 2009 / 58(SS10),1–20.
  19. Saint-Raymond A, Seigneuret N. The European paediatric initiative: 1 year of experience. Paediatric Drugs. 2009;11(1):9–10
  20. Schirm E, Tobi H, Zito JM, de Jong-van den Berg LT. Psychotropic medication in children: a study from the Netherlands. Pediatrics. 2001;108:E25
  21. Tobi H, Scheers T, Netjes KA, Mulder EJ, de Bildt A, Minderaa RB. Drug utilisation by children and adolescents with mental retardation: a population study. European Journal of Clinical Pharmacology. 2005;61(4):297–302
  22. Vitiello B. Pharmacoepidemiology and pediatric psychopharmacology research. Journal of Child and Adolescent Psychopharmacology. 2005;15:10–11
  23. Vitiello B. Recent developments and strategies in pediatric pharmacology research in the USA. The Child. 2008;2:36
  24. Vitiello B, Correll C, van Zwieten-Boot B, Zuddas A, Parellada M, Arango C. Antipsychotics in children and adolescents: increasing use, evidence for efficacy and safety concerns. European Neuropsychopharmacology. 2009;19(9):629–635Sep
  25. Walkup JT, Cruz K, Kane S, Geller B. The future of pediatric psychopharmacology. Clinics of North America. 1998;45(5):1265–1278Oct
  26. Weissman MM, Klerman GL. Depression: current understanding and changing trends. Annual Review of Public Health. 1992;13:319–339
  27. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E., 2004. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. Apr 24, 363,9418,1341–5.
  28. Wohlfarth T, van Zwieten BJ, Lekkerkerker FJ, Gispen-de Wied CC, Ruis JR, Elferink AJ, et al. Antidepressants use in children and adolescents and the risk of suicide. European Neuropsychopharmacology. 2006;16:79–154
  29. Wohlfarth T, Kalverdijk L, Rademaker C, Schothorst P, Minderaa R, Gispen-de Wied C. Psychopharmacology for children: from off label use to registration. European Neuropsychopharmacology. 2009;19:603–608
  30. Zito JM, Safer DJ, Dosreis S, Gardner JF, Boles M, Lynch F. Trends in the prescribing of psychotropic medications to preschoolers. JAMA: The Journal of the Amelrican Medical Association. 2000;283(8):1025–1030

PII: S0924-977X(10)00138-0

doi: 10.1016/j.euroneuro.2010.06.011

European Neuropsychopharmacology
Volume 21, Issue 8 , Pages 565-570 , August 2011