Placebo-controlled Trials in Schizophrenia: Are They Ethical? Are They Necessary?
Document Type
Article
Publication Date
2-15-1999
Source
Schizophrenia Research
Volume
35
Issue
3
First Page
211
Last Page
218
URL with Digital Object Identifier
http://dx.doi.org/10.1016/S0920-9964(98)00127-3
Abstract
The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the use of placebo may be the cause of the problem pointed to. Scientific, regulatory, ethical and legal advantages of the use of an active control are described. While the use of a placebo control may be acceptable in carefully defined circumstances, in most cases the use of an active control in schizophrenia research is ethically and scientifically preferable.
Notes
Dr. Charles Weijer is currently a faculty member at The University of Western Ontario.