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Clinical Review

Efficacy and safety of antidepressants for children and adolescents

BMJ 2004; 328 doi: (Published 08 April 2004) Cite this as: BMJ 2004;328:879

This article has a correction. Please see:

  1. Jon N Jureidini, head (,
  2. Christopher J Doecke, associate professor of pharmacy practice2,
  3. Peter R Mansfield, research fellow3,
  4. Michelle M Haby, senior epidemiologist5,
  5. David B Menkes, professor of psychological medicine6,
  6. Anne L Tonkin, associate professor4
  1. 1Department of Psychological Medicine, Women's and Children's Hospital,North Adelaide, 5006 SA, Australia
  2. 2Quality Use of Medicines and Pharmacy Research Centre, University of South Australia, Adelaide, 5000 SA
  3. 3Department of General Practice, University of Adelaide, Adelaide, 5005 SA,
  4. 4Department of Clinical and Experimental Pharmacology, University of Adelaide,
  5. 5Health Surveillance and Evaluation Section, Public Health, Departmentof Human Services, Melbourne, 3000 Vic, Australia
  6. 6University of Wales Academic Unit, Wrexham LL13 7YP
  1. Correspondence to: J N Jureidini
  • Accepted 2 March 2004

How safe and effective are antidepressants in children and adolescents? The authors of this review have found disturbing shortcomings in the methods and reporting of trials of newer antidepressants in this patient group


Antidepressants introduced since 1990, especially selective serotonin reuptake inhibitors and venlafaxine, have been used increasingly as first line treatment for depression in children.1 2 The safety of prescribingantidepressants to children (including adolescents) has been the subject of increasing concern in the community and the medical profession, leading to recommendations against their use from government and industry (box 1). In this paper, we review the published literature on the efficacy and safety of newer antidepressants in children.


Having criticised the way in which Keller et al interpreted the results of their study,3 4 we sought to check the quality of methods and reporting of other published trials of newer antidepressants in children (box 2). Of seven published randomised controlled trials of newer antidepressants for depressed children published in refereed journals, six used a placebo control.359 We analysed eachstudy's methods and the extent to which authors' conclusions were supported by data. The seventh study, which compared a newer antidepressant with a tricyclic antidepressant without finding significant difference,10 was not included in the analysis but appears in the table on

Box 1: Warnings about antidepressants in children

June 2003—Letter from GlaxoSmithKline to all medical practitioners in the United Kingdom actively discouraging the use of paroxetine in patients less than 18 years of age, on the basis of recently disclosed trial results showing unacceptable risk of serious adverse effects,including hostility and 17 Mar 2004)

June 2003—Warning from the UK Committee on Safety of Medicines against the use of paroxetine 1 Mar 2004)

August 2003—Warnings about venlafaxine, promulgated by the 30 Dec …

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