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Empirically derived criteria cast doubt on the clinical significance of antidepressant-placebo differences

Moncrieff, J; Kirsch, I; (2015) Empirically derived criteria cast doubt on the clinical significance of antidepressant-placebo differences. Contemporary Clinical Trials , 43 pp. 60-62. 10.1016/j.cct.2015.05.005. Green open access

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Abstract

Meta-analyses indicate that antidepressants are superior to placebos in statistical terms, but the clinical relevance of the differences has not been established. Previous suggestions of clinically relevant effect sizes have not been supported by empirical evidence. In the current paper we apply an empirical method that consists of comparing scores obtained on the Hamilton rating scale for depression (HAM-D) and scores from the Clinical Global Impressions-Improvement (CGI-I) scale. This method reveals that a HAM-D difference of 3 points is undetectable by clinicians using the CGI-I scale. A difference of 7 points on the HAM-D, or an effect size of 0.875, is required to correspond to a rating of ‘minimal improvement’ on the CGI-I. By these criteria differences between antidepressants and placebo in randomised controlled trials, including trials conducted with people diagnosed with very severe depression, are not detectable by clinicians and fall far short of levels consistent with clinically observable minimal levels of improvement. Clinical significance should be considered alongside statistical significance when making decisions about the approval and use of medications like antidepressants.

Type: Article
Title: Empirically derived criteria cast doubt on the clinical significance of antidepressant-placebo differences
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.cct.2015.05.005
Publisher version: https://doi.org/10.1016/j.cct.2015.05.005
Language: English
Additional information: This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Antidepressant efficacy, Clinical relevance of antidepressant effects, Hamilton rating scale for depression, Measurement of depression, Effect size in depression
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
URI: https://discovery.ucl.ac.uk/id/eprint/1490778
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