Efficacy and effectiveness of antidepressants: current status of research.
BACKGROUND
This paper examines the current status of research on the efficacy and effectiveness of antidepressants.


METHODS
This paper reviews four meta-analyses of efficacy trials submitted to America's Food and Drug Administration (FDA) and analyzes STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted.


RESULTS
Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy. These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest. The STAR*D analysis found that the effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study authors with an apparent progressively increasing dropout rate across each study phase.


CONCLUSIONS
The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.
Pigott
H Edmund
HE
NeuroAdvantage, LLC, Clarksville, Md., USA. pathware@erols.com
Leventhal
Allan M
AM
Alter
Gregory S
GS
Boren
John J
JJ
D000928:Antidepressive Agents / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy*; D006801:Humans; D015201:Meta-Analysis as Topic; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D055502:Secondary Prevention; D016896:Treatment Outcome
D000928:Antidepressive Agents