The Use of Placebo-Controlled Clinical Trials for the Approval of Psychiatric Drugs: Part II-Ethical Considerations Related to the Individual Participant.

Abstract

This is Part 2 of a two-part series on the ethical issues surrounding the use of placebo arms in clinical trials for psychiatric drugs. Part 1 discussed the ethical argument from a statistical, population-based perspective. Part 2 explores the ethical issues of placebo-controlled studies as they relate to individual psychiatric patients who may participate in them. Many patients who are candidates for psychiatric clinical trials would receive poor treatment for their mental illness under standard treatment conditions. Industry-sponsored clinical trials often provide treatment resources otherwise not available to patients at a more intense level of care than the local standard. Moreover, study design features, such as those developed at University of California, San Diego (presented herein), can mitigate the risks of placebo arms. With this in mind, clinical trials represent an ethical option for many patients with chronic mental illness.