title: Health-related quality of life in patients with schizophrenia during treatment with long-acting, injectable risperidone.
abstract: BACKGROUND
  We investigated the impact of treatment with long-acting, injectable risperidone versus placebo on health-related quality of life (HRQoL) in patients with schizophrenia. Results are discussed in the context of HRQoL in the general U.S. population.
  
  
  METHODS
  Patients with DSM-IV schizophrenia entered a randomized, double-blind, placebo-controlled trial. After screening, previous antipsychotics were discontinued, and oral risperidone was titrated up to a dose of 4 mg/day over 1 week. Patients were then randomly assigned to receive placebo [N = 92] or long-acting risperidone (25 [N = 93], 50 [N = 97], or 75 mg [N = 87] every 2 weeks) for 12 weeks. HRQoL was measured using the Medical Outcomes Study Short-Form 36-item questionnaire (SF-36).
  
  
  RESULTS
  At week 12, patients receiving long-acting risperidone had improved significantly (p <.05) in 5 domains of the SF-36 (bodily pain, general health, social functioning, role-emotional, and mental health) compared with patients receiving placebo. The effect was greatest for the 25-mg group, with significant improvement versus placebo in 6 domains (p <.05). At baseline, all SF-36 domain scores except bodily pain were significantly lower (p <.05) than normal values in all groups. With placebo, scores in all 8 domains remained below normal values after 12 weeks, while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels, with clinically meaningful improvements in all mental-health domains. In the 25-mg group, scores in 7 domains were not statistically different from normal values after 12 weeks.
  
  
  CONCLUSIONS
  Long-acting, injectable risperidone improved HRQoL toward normal levels. After 12 weeks, HRQoL of patients receiving 25 mg was not significantly different from normal.
authors.affiliation: Department of Psychiatry, Neurology, and Neuroscience, University of Cincinnati Medical Center, 231 Albert Sabin Way, PO Box 670559, Cincinnati, OH 45267-0559, USA. henry.nasrallah@uc.edu
authors.forename: Henry A
authors.initials: HA
authors.lastname: Nasrallah
authors.forename: Inge
authors.initials: I
authors.lastname: Duchesne
authors.forename: Angelika
authors.initials: A
authors.lastname: Mehnert
authors.forename: Carmela
authors.initials: C
authors.lastname: Janagap
authors.forename: Mariëlle
authors.initials: M
authors.lastname: Eerdekens
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006304:Health Status; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D010919:Placebos; D011788:Quality of Life / Q000523:psychology; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D010919:Placebos; D018967:Risperidone