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April 10, 2002

Placebo in Clinical Trials for Depression: Complexity and Necessity

Author Affiliations

Author Affiliations: Department of Psychiatry, University of Pittsburgh Medical School, Western Psychiatric Institute and Clinic, Pittsburgh, Pa.

JAMA. 2002;287(14):1853-1854. doi:10.1001/jama.287.14.1853

Within the last several years, the long-simmering debate about the ethical issues surrounding placebo administration in randomized clinical trials has reached new levels of intensity. The report of the National Bioethics Advisory Commission included specific recommendations for studies involving more than minimal risk, including the use of placebo controls in clinical trials.1 At a time of increased interest in drug discovery in medicine and the potential need for definitive randomized clinical trials, the controversy over the ethical issues places an appropriate burden on the scientific community to justify the use of placebo controls.2,3 One argument is that placebo administration is not appropriate if effective treatment for a condition exists and that assessment of efficacy can be conducted with active controls. Another view is that placebo controls may be necessary to determine the assay sensitivity of a trial and are ethical if patients provide informed consent and are not harmed.4