Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.

<h4>Background</h4>Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also d...

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Autores principales:	Irving Kirsch, Brett J Deacon, Tania B Huedo-Medina, Alan Scoboria, Thomas J Moore, Blair T Johnson
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2008
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/2c20cf1281c54e7bb3bcbb38e195c644
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spelling	oai:doaj.org-article:2c20cf1281c54e7bb3bcbb38e195c6442021-11-25T05:37:05ZInitial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.1549-12771549-167610.1371/journal.pmed.0050045https://doaj.org/article/2c20cf1281c54e7bb3bcbb38e195c6442008-02-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/18303940/?tool=EBIhttps://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.<h4>Methods and findings</h4>We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug-placebo difference scores. Drug-placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.<h4>Conclusions</h4>Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.Irving KirschBrett J DeaconTania B Huedo-MedinaAlan ScoboriaThomas J MooreBlair T JohnsonPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 5, Iss 2, p e45 (2008)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Irving Kirsch Brett J Deacon Tania B Huedo-Medina Alan Scoboria Thomas J Moore Blair T Johnson Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
description	<h4>Background</h4>Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.<h4>Methods and findings</h4>We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug-placebo difference scores. Drug-placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.<h4>Conclusions</h4>Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.
format	article
author	Irving Kirsch Brett J Deacon Tania B Huedo-Medina Alan Scoboria Thomas J Moore Blair T Johnson
author_facet	Irving Kirsch Brett J Deacon Tania B Huedo-Medina Alan Scoboria Thomas J Moore Blair T Johnson
author_sort	Irving Kirsch
title	Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
title_short	Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
title_full	Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
title_fullStr	Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
title_full_unstemmed	Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
title_sort	initial severity and antidepressant benefits: a meta-analysis of data submitted to the food and drug administration.
publisher	Public Library of Science (PLoS)
publishDate	2008
url	https://doaj.org/article/2c20cf1281c54e7bb3bcbb38e195c644
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Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.

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