Commentary on “Cognition in schizophrenia”

Abstract

The ECNP hosted an open consultation meeting on cognitive impairment in schizophrenia and the discussion from this meeting is summarized in this issue. The resulting commentary is a clear and helpful summary of recent developments in this area. I wish to clarify and elaborate on some points raised by the commentary. The first thing a reader notices is the breadth of the commentary title: “Cognition in Schizophrenia.” It is difficult to wrap one's arms around an elephant. Journals such as Schizophrenia Research and Schizophrenia Bulletin include in every issue a large number of articles, using a range of methods and approaches, that all fit comfortably under this title. With such a broad title, the question is: what is the focus of this commentary? Though touching on a range of topics and variety of clinical disorders, there appear to be two areas of emphasis: one on drug development for cognition enhancement in schizophrenia, and one on the role of cognitive impairment in diagnosis. Regarding the first emphasis on cognition enhancement, the commentary summarizes regulatory issues, including the role of co-primary measures (energetically referred to as the “crisis of co-primary outcomes”). And this is indeed a preoccupying issue for the field. The United States Food and Drug Administration (FDA) has taken the position that, to receive approval, a drug for the treatment of cognitive impairment in schizophrenia needs to improve cognitive performance and a functionally meaningful co-primary measure. A clear precedent for the requirement of co-primary measures comes from treatment development for dementia. It is notable that the FDA is currently seeking feedback on a proposal to change this requirement for early-stage dementia