title: Defining therapeutic benefit for people with schizophrenia: focus on negative symptoms.
abstract: Schizophrenia is a complex, heterogeneous, multidimensional disorder within which negative symptoms are a significant and disabling feature. Whilst there is no established treatment for these symptoms, some pharmacological and psychosocial interventions have shown promise and this is an active area of research. Despite the effort to identify effective interventions, as yet there is no broadly accepted definition of therapeutic success. This article reviews concepts of clinical relevance and reports on a consensus conference whose goal was to apply these concepts to the treatment of negative symptoms. A number of key issues were identified and discussed including: assessment of specific negative symptom domains; defining response and remission for negative symptoms; assessment of functional outcomes; measurement of outcomes within clinical trials; and the assessment of duration/persistence of a response. The group reached a definition of therapeutic success using an achieved threshold of function that persisted over time. Recommendations were agreed upon with respect to: assessment of negative symptom domains of apathy-avolition and deficit of expression symptoms; thresholds for response and remission of negative symptoms based on level of symptomatology; assessing multiple domains of function including social occupation, activities of daily living, and socialization; the need for clinical trial data to include rate of change over time and converging sources of evidence; use of clinician, patient and caregiver perspectives to assess success; and the need for establishing criteria for the persistence of therapeutic benefit. A consensus statement and associated research criteria are offered as an initial step towards developing broad agreement regarding outcomes of negative symptoms treatment.
authors.affiliation: State University of New York, Downstate Medical Center, Brooklyn, NY, USA. Electronic address: nina.schooler@gmail.com.
authors.forename: Nina R
authors.initials: NR
authors.lastname: Schooler
authors.affiliation: Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Buchanan
authors.affiliation: Laughren Psychopharm Consulting, LLC, Rockville, MD, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Laughren
authors.affiliation: Department of Psychiatry and Psychotherapy, Technische Universität University Hospital, Munich, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Leucht
authors.affiliation: Department of Neurology and Psychiatry, Saint Louis University School of Medicine, St. Louis, MO, USA.
authors.forename: Henry A
authors.initials: HA
authors.lastname: Nasrallah
authors.affiliation: Department of Psychiatry and Human Behavior, University of CA, Irvine, USA.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Potkin
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: Danielle
authors.initials: D
authors.lastname: Abi-Saab
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: Carmen Galani
authors.initials: CG
authors.lastname: Berardo
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: Dragana
authors.initials: D
authors.lastname: Bugarski-Kirola
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Blaettler
authors.affiliation: Roche Products Ltd., Welwyn, UK.
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Edgar
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: Anna-Lena
authors.initials: AL
authors.lastname: Nordstroem
authors.affiliation: Intra-Cellular Therapies, Inc. New York, NY, USA.
authors.forename: Cedric
authors.initials: C
authors.lastname: O'Gorman
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland.
authors.forename: George
authors.initials: G
authors.lastname: Garibaldi
mesh_terms: D003245:Consensus Statements as Topic; D006801:Humans; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology
keywords: Clinical relevance; Function; Negative symptoms; Schizophrenia