Development and evaluation of psychotropic drugs

Existing pharmacological treatments for mental disorders are not ideal, and there is much scope for the development of new compounds likely to be associated with improved effectiveness and acceptability in clinical practice. The appearance of a novel psychotropic drug treatment is the result of many years of diligent work from pre-clinical and clinical scientists and considerable scrutiny from regulatory bodies. Most compounds with the potential for clinical use do not enter the comparatively late stage of randomized controlled trials, and some medications are withdrawn from use once safety and tolerability problems are identified in routine clinical samples. This contribution describes the phases of psychotropic drug development, highlights some aspects of study design in the evaluation of potential treatments prior to licensing, and considers likely future challenges in this research environment.