Considerations on the placebo control of clinical trials in the treatment of depression
10.13699/j.cnki.1001-6821.2015.16.040
- VernacularTitle:抗抑郁药物临床试验中采用安慰剂对照的考虑要素
- Author:
Hao LIU
1
;
Ying GENG
;
De-Heng ZHAO
;
Zhi-Min YANG
Author Information
1. 武汉大学 人民医院 精神卫生中心
- Keywords:
antidepressant;
clinical trial;
placebo;
control
- From:
The Chinese Journal of Clinical Pharmacology
2015;(16):1692-1695
- CountryChina
- Language:Chinese
-
Abstract:
When to design clinical trials in the treatment of depression, we should follow some general rules of ordinary clinical trials, and also have to consider the characteristics of depression and test drugs, as well as the influence of these characteristics.Due to the questionable efficacy of active drug in the treatment of depression,placebo control could apply a potent evidence to clarify the absolute efficacy of test drugs.In this ar-ticle, the present situation of placebo control in these studies was intro-duced, we interpreted the general considerations on placebo control of these studies from ethnics and safety aspects, and analysed the factors which may contribute to the drug-placebo difference, and finally provid-ed suggestions about how to design these studies with placebo control, which may help sponsors and drug research units to obtain a systematic understanding of placebo control in these studies.
