Psychotropic medications have been dramatically successful over the since the 1950s, but severe problems remain. The World Health Organization (WHO) has a legal responsibility to review these drugs, estimate their benefit/risk ratio, help ensure their proper prescription and recommend which ones require international controls. This book utilizes the experience of the WHO to provide information about how such drugs should be evaluated, such as the planning, executing, monitoring, analyzing, interpreting and reporting involved with correctly making such evaluations. Subjects range from the evaluation of drugs from primary studies in healthy volunteers to the longitudinal study of drugs in routine use. Further chapters examine special issues in the evaluations of drug effects upon children and the elderly. There is also a section on study design and a final brief chapter on some transcultural issues.

A source book in clinical methods for the understanding of psycho- pharmacologic agents and clinical evaluation of drugs in the treatment of mental disorder, produced in association with the National Institute of Mental health and the American College of Neuropsychopharmacology. The volume consists of three main sections. The first addresses the historical context of clinical psychopharmacologic research and guidelines and the decision process involved in drug development and evaluation. Section II addresses broad developments and issues for clinical methodology, providing guidance in research principles, study design and implementation, reporting of study findings, and ethical considerations involving drug evaluations. Section III provides methodologic developments and recommendations for research involving specific patient populations. Annotation copyright by Book News, Inc., Portland, OR

The idea of placebo-controlled drug trials and the advent of test statistics during the first part of this century were the major milestones in the establishment of a convincing methodology for demonstrating the efficacy of treatments. The first tricyclic and neuroleptic drugs were tested for their efficacy in psychiatric disorders along the lines of these methodological developments, but subsequent trials with psychotropic drugs did not adhere to these principles to the same extent because it became difficult to justify placebo-controlled trials once effective treatments had been established. Consequently, the second generation of an tidepressants and neuroleptics (since the early 1960s) were mainly tested, in Europe at least, in samples of patients using trials controlled by standard treatment only, and the methodological basis of these second generation trials became fragile, as will be demonstrated by several papers in this book. This development did not provoke much discussion until recently, when scientific and administrative interest in the methodology of the evaluation of psychotropic drugs increased substantially. A series of factors contribute to the growing interest in the standards of psychotropic drug trials: 1. The proportion of psychiatric patients resistant to treatment is growing; the efficacy of well-established forms of treatment therefore seems to be limited. 2. A series of psychotropic drugs were withdrawn from the market, mainly because they caused serious side effects. The efficacy and safety ofthese drugs had previously been demonstrated in drug trials, which raised the question whether the drug trials carried out were well-designed.

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