Journal
JOURNAL OF PSYCHOPHARMACOLOGY
Volume 34, Issue 10, Pages 1074-1078Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/0269881120922950
Keywords
Depression; antidepressants; meta-analysis; efficacy; clinical trials
Funding
- Lundbeck Foundation
- Lennander's Foundation
- National Institute for Health Research Biomedical Research Centre at South London, Maudsley National Health Service Foundation Trust, King's College London
- Royal College of Physicians, Edinburgh
- Independent Research Fund Denmark
- Novo Nordisk Foundation
- Canadian Institutes of Health Research (CIHR Canada)
- Brain & Behavior Research Foundation
- Stanley Medical Research Institute (USA)
- Medical Research Council (UK)
- Wellcome Trust (UK)
- Royal College of Physicians (Edin)
- British Medical Association (UK)
- Vancouver General Hospital-University of British Colombia Foundation (Canada)
- CCS Depression Research Fund (Canada)
- Michael Smith Foundation for Health Research (Canada)
- National Institute for Health Research (UK)
- Janssen (UK)
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The efficacy of antidepressants in major depressive disorder has been continually questioned, mainly on the basis of studies using the sum-score of the Hamilton Depression Rating Scale as a primary outcome parameter. On this measure antidepressants show a standardised mean difference of around 0.3, which some authors suggested is below the cut-off for clinical significance. Prompted by a recent review that, using this argument, concluded antidepressants should not be used for adults with major depressive disorder, we (a) review the evidence in support of the cut-off for clinical significance espoused in that article (a Hamilton Depression Rating Scale standardised mean difference of 0.875); (b) discuss the limitations of average Hamilton Depression Rating Scale sum-score differences between groups as measure of clinical significance; (c) explore alternative measures of clinical importance; and (d) suggest future directions to help overcome disagreements on how to define clinical significance. We conclude that (a) the proposed Hamilton Depression Rating Scale cut-off of 0.875 has no scientific basis and is likely misleading; (b) there is no agreed upon way of delineating clinically significant from clinically insignificant; (c) evidence suggests the Hamilton Depression Rating Scale sum-score underestimates antidepressant efficacy; and (d) future clinical trials should consider including measures directly reflective of functioning and wellbeing, in addition to measures focused on depression psychopathology.
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