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

ABSTRACT:

Background

Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance.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is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.

Methods and findings

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

SUBMITTER: Kirsch I 

PROVIDER: S-EPMC2253608 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature