Guidelines for the use of placebo controls in clinical trials of psychopharmacologic agents

Federal regulations governing pharmacologic research require scientific proof of efficacy. Although these regulations are often interpreted to mean that a placebo-controlled trial is necessary, it is difficult to justify use of placebo controls when effective standard therapy exists. Justification is especially problematic in psychopharmacologic research because of the added concern that subjects with compromised decision-making capacity cannot give valid consent. To promote discussion and consensus, this article presents guidelines for the ethically justifiable use of placebo controls in research with psychopharmacologic agents. The guidelines, developed by a university's institutional review board, are designed to help investigators design studies and to protect vulnerable subjects.