title: Methodological issues in negative symptom trials.
abstract: Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms.
authors.affiliation: The Semel Institute for Neuroscience at University of California, Los Angeles, CA, USA.marder@ucla.edu
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Marder
authors.forename: David G
authors.initials: DG
authors.lastname: Daniel
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
authors.forename: A George
authors.initials: AG
authors.lastname: Awad
authors.forename: Richard S E
authors.initials: RS
authors.lastname: Keefe
mesh_terms: D000342:Affective Symptoms / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced / Q000175:diagnosis; D002986:Clinical Trials as Topic / Q000379:methods*; D003072:Cognition Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D032921:Consensus; D003299:Cooperative Behavior; D004345:Drug Industry; D004359:Drug Therapy, Combination; D004493:Education; D006801:Humans; D033183:Interdisciplinary Communication; D007391:International Cooperation; D009460:Neurologic Examination / Q000187:drug effects; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011594:Psychometrics; D012107:Research Design; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D014150:Antipsychotic Agents