title: Long-acting risperidone and oral antipsychotics in unstable schizophrenia.
abstract: BACKGROUND
  Long-acting injectable risperidone, a second-generation antipsychotic agent, may improve adherence to treatment and outcomes in schizophrenia, but it has not been tested in a long-term randomized trial involving patients with unstable disease.
  
  
  METHODS
  We randomly assigned patients in the Veterans Affairs (VA) system who had schizophrenia or schizoaffective disorder and who had been hospitalized within the previous 2 years or were at imminent risk for hospitalization to 25 to 50 mg of long-acting injectable risperidone every two weeks or to a psychiatrist's choice of an oral antipsychotic. All patients were followed for up to 2 years. The primary end point was hospitalization in a VA or non-VA psychiatric hospital. Symptoms, quality of life, and functioning were assessed in blinded videoconference interviews.
  
  
  RESULTS
  Of 369 participants, 40% were hospitalized at randomization, 55% were hospitalized within the previous 2 years, and 5% were at risk for hospitalization. The rate of hospitalization after randomization was not significantly lower among patients who received long-acting injectable risperidone than among those who received oral antipsychotics (39% after 10.8 months vs. 45% after 11.3 months; hazard ratio, 0.87; 95% confidence interval, 0.63 to 1.20). Psychiatric symptoms, quality of life, scores on the Personal and Social Performance scale of global functioning, and neurologic side effects were not significantly improved with long-acting injectable risperidone as compared with control treatments. Patients who received long-acting injectable risperidone reported more adverse events at the injection site and more extrapyramidal symptoms.
  
  
  CONCLUSIONS
  Long-acting injectable risperidone was not superior to a psychiatrist's choice of oral treatment in patients with schizophrenia and schizoaffective disorder who were hospitalized or at high risk for hospitalization, and it was associated with more local injection-site and extrapyramidal adverse effects. (Supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs; ClinicalTrials.gov number, NCT00132314.).
authors.affiliation: Veterans Affairs (VA) New England Mental Illness, Research Education and Clinical Center, VA Connecticut Healthcare System, West Haven, CT 06516, USA. robert.rosenheck@va.gov
authors.forename: Robert A
authors.initials: RA
authors.lastname: Rosenheck
authors.forename: John H
authors.initials: JH
authors.lastname: Krystal
authors.forename: Robert
authors.initials: R
authors.lastname: Lew
authors.forename: Paul G
authors.initials: PG
authors.lastname: Barnett
authors.forename: Louis
authors.initials: L
authors.lastname: Fiore
authors.forename: Danielle
authors.initials: D
authors.lastname: Valley
authors.forename: Soe Soe
authors.initials: SS
authors.lastname: Thwin
authors.forename: Julia E
authors.initials: JE
authors.lastname: Vertrees
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Liang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006787:Hospitals, Veterans; D006801:Humans; D007273:Injections, Intramuscular; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016016:Proportional Hazards Models; D011788:Quality of Life; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D018967:Risperidone