Ethical and Scientific Perspectives of Placebo-controlled Trials in Schizophrenia

Abstract

Clinical trials for development of new medications are essential in all fields of medicine. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. On the other hand, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when the investigational drug may ultimately provide substantial benefit for some patients. At the same time it is the psychiatrist's responsibility to insure that investigators are adequately trained to conduct clinical trials and that stringent regulatory committees supervise the scientific, clinical and ethical aspects of the trials.KeywordsPlacebo-control; Schizophrenia; Medical ethics; Clinical trials

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan

“…Researchers prefer situations in which studies demonstrate that a new drug is equally effective as the active-control drug. However, some medications that are currently available and considered effective have not always been proven as such in comparison to placebo [ 22 , 23 ]. Furthermore, the instruments used for measurement in psychiatry are often subject to measurement error due to the nature of observation, self-report or interview.…”

Schizophrénie et consentement à la recherche biomédicale

“…De plus, certains protocoles peuvent poser des problèmes éthiques car ils comportent des risques non négligeables, et imposent une réelle capacité à consentir chez les sujets participant [19]. C'est notamment le cas des études avec utilisation de placebo, des études de provocation des symptômes, des études avec période d'interruption des traitements (le « wash-out » des études pharmacologiques) [20].…”