Placebo-Controlled Studies in Depression: Necessity and Feasibility

Abstract

The general principles of drug evaluation in psychiatry have now been widely accepted, although it has taken some time for methodologies suitable for each specific situation to evolve and be refined, and further developments continue to occur. Comparison of a new antidepressant with a placebo is required before acceptance by most of the major national regulatory authorities, particularly the FDA, but is still questioned by some clinicians more than most aspects of trial design, so that it can be difficult to recruit sufficient investigators. The issues that it raises still therefore need separate consideration.