A regulatory Apologia
详细信息 查看全文
- 作者：Hans Mel ; er ; Tomas Salmonson ; Eric Abadie ; Barbara van Zwieten-Boot
- 关键词：Major depression ; Placebo ; Clinical relevance
- 刊名：European Neuropsychopharmacology
- 出版年：2008
- 出版时间：September 2008
- 年：2008
- 卷：18
- 期：9
- 页码：623-627
- 全文大小：329 K
文摘
Data on percentage of patients experiencing a relevant response (> 50 % reduction of the baseline Hamilton Depression Scale (HAMD) score), average baseline severity and sample size were retrieved for all placebo-controlled studies in regulatory submissions of SSRIs and SNRIs between 1984 and 2003. Overall there was 16 % -units (95 % CI: 12; 20) more responders on active drug compared to placebo. There was no evidence of a diminishing magnitude of effect with lower severity at baseline. With one exception significant differences varying between 13.5 and 19.3 % -units were demonstrated for the individual antidepressants. Statistically significant mean differences versus placebo in change in HAMD are not a proper basis for evaluation of clinical relevance and are not sufficient for approval. Differences in the percentage of patients experiencing a clinically relevant response should also be demonstrated. In this respect, the approved SSRIs and SNRIs were found superior to placebo, independent of severity of depression.