How to Perform Phase II Trials in Psychiatry

Phase II clinical trials is a cornerstone of the drug development process since beyond the dose-effect study, phase II trials also largely participate to the evaluation of the drug efficacy. Due to the development of randomized, double-blind, placebo-controlled studies, phase II trials are actually much closed to phase III studies in terms of methodology. Indeed, groups of patients should be uniform and representative with regard to the disease, baseline characteristics and expected response to the treatment. In the field of psychopharmacology as in many others, an important attention is also given to the evaluation of the clinical effect as well as to the sources of variability. Keywords: Phase II; Clinical trial; Methodology; Psychopharmacology; Psychotropic drug