CONTEMPORARY PROBLEMS OF CLINICAL STUDIES OF NEW ANXIOLYTICS AND ANTIDEPRESSANTS

Abstract

Background: Results and quality of clinical trials are crucial for the clinical practice since these two parameters are reviewed in clinical guidelines. Though there are many identified flaws of the clinical trials of new antidepressants and anxiolytics were strongly criticized. This review aimed to summarize literature from past two decades on methodic and methodological issues of clinical trial of new agents for the treatment of depressive and anxiety disorders. Results: Clinical trials of antidepressants and anxiolytics inherit common trials problems, but also have some specific issues. Modern procedures and requirements to clinical research of new drugs perform formal tasks for the ultimate goal of official registration of the drug but are not fully acceptable for psychiatry at this stage. Some features of mental disorders classification, lack of understanding of the underlying mechanisms, limitations of psychometric methods, under-controlled placebo effect and many other problems on the part of organizers, performers and subjects of clinical trials can lead to biases in the results. A number of other problems, including ignoring the evaluation of the specific dimensions of the clinical and pharmacological action of the drug, limit the generalizability of the study results. Conclusions: the emergence of more effective solutions to these problems will increase the adequacy of various aspects of the studies, beginning with the formation of the study hypothesis, selection of efficacy endpoints, study population, and may yield results that could be applied not only to a formalized assessment of the drug efficacy, but also a real-world personalized / stratified prognosis of effectiveness in real clinical settings.