Methods to Facilitate Early Exploratory Testing of Novel Psychopharmacologic Agents in Humans

Abstract

The starting point for this chapter follows from three assumptions: (1) substantial numbers of patients seriously ill with psychiatric illnesses such as schizophrenia and depression show inadequate therapeutic responses to all available classes of drugs; (2) decisions to take new potential psychotropic compounds into humans are more and more based on judgments as to the likelihood of there being a reasonable market for that specific compound; and (3) pharmacologic guidance can greatly enhance the efficiency of the clinical development process both in terms of reducing wasted effort in Phase I testing and of deriving maximum information concerning the appropriate dose to test the therapeutic potential of a novel compound. With regard to this latter point, it is well known that even marketed psychotropic drugs have had very misleading dose recommendations because what is required for marketing is to establish safe doses which on average have a positive effect rather than doses which produce the maximum possible benefit.