Clinical research in psychopharmacology: new standards for drug development. An application to antidepressants

Abstract

SummaryThis paper compares the report of the consensus conference on the methodology of clinical trials of antidepressants held in Zurich in 1988 with the second edition of the WHO Clinical Consensus Document. For the pilot trials, the dose-finding studies, the main therapeutic trials and the long-term trials, the following problems are discussed: inclusion and exclusion criteria, assessments of the severity of depression and of side-effects, measurement of change, recommended length of trials and criteria for the degree of response. It is important to obtain evidence to establish that antidepressants are sufficiently effective and well-tolerated over a long period of time to justify their continued use. At least 100 patients treated for a period of one year should be available. During these trials, self-rating scales for quality of life are useful as are reports of any severe drug reactions, forwarded to the National Adverse Drug Reaction Monitoring System.