Do DSM classifications help or hinder drug development?

Abstract

Development and regulatory approval of psychotropic drugs targets individuals with syndromes described in the current Diagnostic and Statistical Manual of Mental Disorders (DSM). This helps drug developers and regulators to communicate with prescribers, and prescribers to match a specific psychotropic with the individual patient(s) most likely to benefit from it. However, this practice has been criticized on the grounds that DSM syndromes are too heterogenous biologically, and the effects of psychotropics are too nonspecific to allow for an effective match. This review considers the advantages and disadvantages of the current practice and the possible alternatives. It concludes that efforts should be made to explore psychotropic development transdiagnostically, free of the DSM boundaries. However, currently there exists no alternative diagnostic system that is clearly superior to the DSM in terms of communications between the stakeholders in drug development.