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THE LANCET Infectious Diseases
THE LANCET Neurology
Home The Journal Current Issue Original research
Volume 363, Number 9418     24 April 2004

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Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data

Craig J Whittington, Tim Kendall, Peter Fonagy, David Cottrell, Andrew Cotgrove, Ellen Boddington

Centre for Outcomes Research and Effectiveness, Subdepartment of Clinical Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK (C J Whittington PhD, Prof P Fonagy PhD, E Boddington MSc); Royal College of Psychiatrists' Research Unit, London SW1H 0HW (T Kendall MRCPsych); Academic Unit of Child and Adolescent Mental Health, School of Medicine, University of Leeds, Leeds, UK (Prof D Cottrell FRCPsych); and Pine Lodge Young People's Centre, Chester, UK (A Cotgrove MRCPsych)

Correspondence to: Dr Craig Whittington (


Background Questions concerning the safety of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depression in children led us to compare and contrast published and unpublished data on the risks and benefits of these drugs.

Methods We did a meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines. The following outcomes were included: remission, response to treatment, depressive symptom scores, serious adverse events, suicide-related behaviours, and discontinuation of treatment because of adverse events.

Findings Data for two published trials suggest that fluoxetine has a favourable risk-benefit profile, and unpublished data lend support to this finding. Published results from one trial of paroxetine and two trials of sertraline suggest equivocal or weak positive risk-benefit profiles. However, in both cases, addition of unpublished data indicates that risks outweigh benefits. Data from unpublished trials of citalopram and venlafaxine show unfavourable risk-benefit profiles.

Interpretation Published data suggest a favourable risk-benefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. Clinical guideline development and clinical decisions about treatment are largely dependent on an evidence base published in peer-reviewed journals. Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment. Greater openness and transparency with respect to all intervention studies is needed.

Lancet 2004; 363: 1341-45

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