Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data
The LancetPublished 1 April 2004
Craig Whittington, Timothy J. Kendall, Peter Fonagy, David Cottrell, Andrew Cotgrove, Ellen Boddington
Citations1,062
SJR quartileQ1
SJR score12.11
SNIP22.72
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
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an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines indicated that risks could outweigh benefits of these drugs to treat depression in children and young people.
Abstract
Published data suggest a favourable risk-benefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people.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.
Keywords
PsychologyMedicine
Statistics in MedicineQuantifying heterogeneity in a meta‐analysis
36,744 Citations2002Julian P. T. Higgins, Simon G. Thompson
It is concluded that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity, and one or both should be presented in publishedMeta-an analyses in preference to the test for heterogeneity.
BMJPharmaceutical industry sponsorship and research outcome and quality: systematic review
2,163 Citations2003Joel Lexchin, Lisa A Bero +2 more
Investigating whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support found systematic bias favours products which are made by the company funding the research.
Archives of General PsychiatryThe Great Smoky Mountains Study of Youth
1,083 Citations1996E. Jane Costello
Poverty was the strongest demographic correlate of diagnosis, in both urban and rural children, in this rural sample of children.
Archives of General PsychiatryA Double-blind, Randomized, Placebo-Controlled Trial of Fluoxetine in Children and Adolescents With Depression
998 Citations1997Graham J. Emslie
Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression, and complete remission of symptoms was rare.
BMJConfidence intervals for the number needed to treat
915 Citations1998Douglas G. Altman
The number needed to treat is the estimated number of patients who need to be treated with the new treatment rather than the standard treatment for one additional patient to benefit in a trial comparing a new treatment with a standard one.
Journal of the American Academy of Child & Adolescent PsychiatryEfficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
648 Citations2001Martin B. Keller, Neal D. Ryan +20 more
Paroxetine demonstrated significantly greater improvement compared with placebo in Hamilton Rating Scale for Depression total score < or = 8, HAM-D depressed mood item, K-SADS-L depressed Mood item, and CGI score of 1 or 2.
BMJEvidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications
639 Citations2003Hans Melander, Jane Ahlqvist-Rastad +2 more
Any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.
Journal of the American Academy of Child & Adolescent PsychiatryFluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial
574 Citations2002Graham J. Emslie, John H. Heiligenstein +6 more
Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients.
JAMAEfficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder<SUBTITLE>Two Randomized Controlled Trials</SUBTITLE>
415 Citations2003Karen Dineen Wagner
The results of this pooled analysis demonstrate that sertraline is an effective and well-tolerated short-term treatment for children and adolescents with MDD.
Journal of the American Academy of Child & Adolescent PsychiatryDEVELOPMENTS IN CHILD PSYCHIATRIC EPIDEMIOLOGY
363 Citations1989John E. Schowalter, E. Jane Costello
Les etudes se basent generalement sur the categorisation du DSM III (3eme edition du Manuel Statistique et Diagnostique des troubles mentaux) sur les facteurs de risques en psychopathologie de l'enfance.
PubMedDeaths: leading causes for 2000.
283 Citations2002Robert N. Anderson
This report supplements the annual report of final mortality statistics and presents final 2000 data on the 10 leading causes of death in the United States by age, race, sex, and Hispanic origin.
Clinical Psychology ReviewPsychosocial treatments for adolescent depression
247 Citations1999Peter M. Lewinsohn
It seems reasonable to conclude that CBT has been demonstrated to be an effective treatment for depressed adolescents, and is suggested by suggesting future directions and several additional areas of application for adolescent depression treatments.
PubMed CentralSystematic Reviews to Support Evidence-Based Medicine: How to Review and Apply Findings of Healthcare Research.
198 Citations2004Melissa Bateson
This is a didactic paperback of a 136 pages which is devoted to the worthy topic of avoiding subjective conclusions in appraising medical publications.
PubMedVenlafaxine in the treatment of children and adolescents with major depression.
147 Citations1997M.W. Mandoki, Mark Tapia +3 more
The statistical analysis indicated a significant improvement over time, but it could not be attributed to venlafaxine drug therapy, and the findings did, however, suggest a low side-effect profile.
Canadian Medical Association JournalDrug company experts advised staff to withhold data about SSRI use in children
79 Citations2004Wayne Kondro
An internal document advised staff at the international drug giant GlaxoSmithKline to withhold clinical trial findings in 1998 that indicated the antidepressant paroxetine had no beneficial effect in treating adolescents.
ACP Journal ClubSystematic Reviews To Support Evidence-Based Medicine: How To Review and Apply Findings of Healthcare Research
79 Citations2004Sharon E. Straus, Darlyne Rath
Systematic Reviews to Support Evidence-Based Medicine provides a concise overview of how to conduct and appraise a systematic review, however, it may not provide sufficient detail for the novice interested in conducting a systematic reviews and it may provide more details than necessary for appraising a systematicreview.
PubMedFacing the evidence: antidepressant treatment in children and adolescents.
72 Citations2004Elizabeth Garland
A large number of young people diagnosed with major depressive disorder in childhood and adolescence have a history of depression that is characterized by a high recurrence rate, particularly around the age of 18.
Journal of Child and Adolescent PsychopharmacologyRemission Status After Long-Term Sertraline Treatment of Pediatric Obsessive-Compulsive Disorder
62 Citations2003Karen Dineen Wagner, Edwin H. Cook +2 more
Sertraline is effective in the treatment of childhood and adolescent OCD, with initial acute response converting to remission and improved functional status in a substantial proportion of patients.
BMJTreatment of major depressive disorder in children and adolescents
47 Citations2004Paul Ramchandani
Most selective serotonin reuptake inhibitors are no longer recommended and there was insufficient evidence to support the use of a fourth, fluvoxamine, following the review of data from clinical trials by an expert working group.
BMJSynthesising licensing data to assess drug safety
28 Citations2004Klim McPherson, Elina Hemminki
Small randomised trials conducted for licensing purposes should record data on adverse results and be made public on the basis of evidence, notwithstanding possible detrimental effects such as an increased risk of breast cancer.