title: Food and Drug Administration perspective on negative symptoms in schizophrenia as a target for a drug treatment claim.
abstract: Negative symptoms of schizophrenia are not adequately addressed by available treatments for schizophrenia. Thus, it is reasonable to consider them as a target for a drug claim. This article describes the thought process that the Food and Drug Administration (FDA) will undertake in considering negative symptoms of schizophrenia as a novel and distinct drug target. Beyond this basic question, this article identifies a number of design issues that the FDA needs to consider regarding how best to conduct studies to support claims for this target. These design issues include (1) what population to study, (2) what phase of illness to target, (3) whether to focus on the negative symptom domain overall or on some specific aspect of negative symptoms, (4) the role of functional measures in negative symptom trials, and (5) optimal designs for targeting drugs for add-on therapy or broad-spectrum agents.
authors.affiliation: Food and Drug Administration, DNDP, HFD-120, 5600 Fishers Lane, Rockville, MD 20853, USA. laughren@cder.fda.gov
authors.forename: Thomas
authors.initials: T
authors.lastname: Laughren
authors.forename: Robert
authors.initials: R
authors.lastname: Levin
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D014150:Antipsychotic Agents