title: Challenging the assumption that improvement in functional outcomes is delayed relative to improvement in symptoms in the treatment of schizophrenia.
abstract: OBJECTIVE
  Functional improvement is generally thought to be distal to improvement in psychiatric symptoms in patients with schizophrenia. In this study, we assessed the effects of early response/non-response to an atypical antipsychotic across multiple outcome measures.
  
  
  METHODS
  This was a randomized, double-blind, flexible-dose, 12-week study that enrolled chronically-ill patients (n=628) diagnosed with schizophrenia or schizoaffective disorder who were experiencing acute symptom exacerbation. Patients were initially assigned to risperidone drug therapy (2-6 mg/day), and their response status at 2 weeks was determined. Early responders (ERs) continued with risperidone therapy, whereas early non-responders (ENRs) were randomized (1:1) in a double-blind manner to either continue on risperidone or switch to another atypical antipsychotic for 10 additional weeks of therapy. Subsequent treatment outcomes were measured by the Quality of Life Scale (QLS), Schizophrenia Objective Functioning Instrument (SOFI), and Subjective Well-being under Neuroleptics (SWN-K) scale.
  
  
  RESULTS
  Compared to ENRs, ERs to risperidone showed significantly more improvement from baseline to endpoint on the QLS total score and all 4 categories (p<.01), the SOFI overall global score and all 4 domains (p<.001), and the SWN-K total score and all 5 subscales (p<.05). Among ERs, the majority of improvement had already been attained by Week 2. There was concordance among clinician- and patient-rated scales across outcomes.
  
  
  CONCLUSIONS
  Improvement across multiple outcome dimensions was not delayed relative to improvement in psychiatric symptoms. Rather, patients who showed an early response to antipsychotic treatment as defined by improvement in psychiatric symptoms also showed early and consistent improvement in functioning, quality of life, and subjective well-being.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. Kinon_Bruce@Lilly.com
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Kinon
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Haya
authors.initials: H
authors.lastname: Ascher-Svanum
authors.forename: Virginia L
authors.initials: VL
authors.lastname: Stauffer
authors.forename: Sara
authors.initials: S
authors.lastname: Kollack-Walker
authors.forename: Wei
authors.initials: W
authors.lastname: Zhou
authors.forename: Shitij
authors.initials: S
authors.lastname: Kapur
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
mesh_terms: D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000503:physiopathology; D011788:Quality of Life; D018967:Risperidone / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D012565:Schizophrenic Psychology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone