PLACEBO-RESPONSE IN GENERALIZED ANXIETY - ITS EFFECT ON THE OUTCOME OF CLINICAL-TRIALS

The development of new treatments for generalized anxiety disorder inc reasingly has been sabotaged by a high placebo-response rate. As a con sequence, and in contrast to the surge of approvals for new antidepres sants, only one new: anxiolytic has been approved by the U.S. Food and Drug Administration in the past 15 years, This article presents a bri ef review of factors that contribute to the placebo response in treatm ent studies of generalized anxiety. Since anxiety is a normal emotion that is sensitive to a variety of life stresses, it is particularly di fficult to achieve the primary goal of a clinical trial, which is to e xtract the ''signal'' of a drug effect from the ''noise'' of backgroun d fluctuations in symptoms. Data from the published literature and fro m the authors' research unit concerning placebo-response trends are re viewed.