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 A series of psychotropic drugs were withdrawn from the market, mainly because they caused serious side effects.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.

Contenu

State of the Art in Drug Trials.- Evaluating Antidepressants and Anxiolytics.- Testing the Efficacy of New Neuroleptic Drugs.- Evaluation of Drugs in Alzheimer's Disease and Age-Associated Memory Impairment.- Testing the Efficacy of New Hypnotic Drugs.- Placebo-Controlled Trials and Ethical Issues.- Placebo-Controlled Studies in Depression: Necessity and Feasibility.- Ethical Problems and Design of Controlled Clinical Trials.- Biostatistics and Measurement of Drug Effects.- Statistical Issues: Sample Size and Dropout.- Measuring the Efficacy of Psychotropic Drugs: Clinical Symptoms and Rating Scales.- Methodological Problems in Assessing Quality of Life as Outcome in Psychopharmacology: A Multiaxial Approach.- Ascertainment of Side Effects in Psychopharmacologic Clinical Trials.- Selection Criteria for Drug Trials.- Diagnoses as Selection Criteria in Drug Trials.- Functional Classification and Response to Psychotropic Drugs.- Append.- National and International Guidelines for the Conduct of Clinical Trials of Psychotropic Drugs.