SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .
Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants
BACKGROUND Recent publications have raised questions over the efficacy and clinical ly relevant effects of antidepressants that have been approved for the treatment of major depression . In this context , the European Commission requested that the European Medicines Agency ( EMEA ) and its scientific committee ( CHMP ) issue an opinion on these data under Article 5(3 ) of Regulation ( EC ) No 726/2004 . FINDINGS Results from a recent meta- analysis [ Kirsch , I. , Deacon , B.J. et al. , ( 2008 ) Initial severity and antidepressant benefits : a meta- analysis of data su bmi tted to the Food and Drug Administration . PLoS Med . 5(2 ) , e45 . ] have question ed the clinical relevance of the use of some antidepressants in treating major depression . This analysis focused only on statistically significant mean differences versus placebo in changes in a rating scale ( such as the Hamilton Depression Rating Scale ) . This , however , would not be an adequate basis for the evaluation of clinical relevance and , from a regulatory perspective , would not be sufficient to grant an antidepressant the approval needed to allow it onto the market . Improvements that are both statistically significant ( based on improvements in vali date d rating scales between baseline and study end ) and clinical ly relevant ( based on responder rates ) need to be shown in short-term studies . In addition , these short-term results need to be confirmed in a r and omised withdrawal study to demonstrate the maintenance of an antidepressant 's effects . CONCLUSIONS The CHMP concluded that the approval of antidepressants for the treatment of patients with major depression is based on data that provide robust and sufficient evidence of clinical ly meaningful benefits for patients with major depression . Therefore , the CHMP is of the opinion that , as no public health concerns have been identified , no regulatory action is necessary on the basis of Kirsch et al. 's findings
SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .