Placebo in the investigation of psychotropic drugs, especially antidepressants.
The paper presents major ethical, legal and methodological problems related to the use of placebo in mental disorders, especially in depression. It is pointed out that although authoritative groups of experts and numerous publications in the field of psychopharmacology indicate advisability of the double blind design with placebo in clinical trials of antidepressants, in recent years there have been more and more voices questioning legitimacy of this method. Objections of an ethical nature are raised, and reliability of this approach is put into doubt from the methodological viewpoint. These issues are discussed in more detail in the paper. Available alternative solutions should be implemented in psychotropic drug studies. The author shares these objections and doubts of an ethical nature, and believes that the placebo procedure is not a necessity in clinical trials of antidepressants.
Puzyński
Stanisław
S
Institute of Psychiatry and Neurology, Warsaw, Poland. puzynsk@ipin.edu.pl
D000928:Antidepressive Agents; D004341:Drug Evaluation / Q000941:ethics* / Q000379:methods / Q000592:standards; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics* / Q000592:standards; D006801:Humans; D010919:Placebos; D011619:Psychotropic Drugs; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods / Q000592:standards
D000928:Antidepressive Agents; D010919:Placebos; D011619:Psychotropic Drugs