title: Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study.
abstract: OBJECTIVE
  The study was designed to evaluate the short-term efficacy and safety of lurasidone in the treatment of acute schizophrenia.
  
  
  METHODS
  Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of double-blind treatment with 40 mg of lurasidone, 120 mg of lurasidone, 15 mg of olanzapine (included to test for assay sensitivity), or placebo, dosed once daily. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score (as the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (as the key secondary efficacy measure).
  
  
  RESULTS
  Treatment with both doses of lurasidone or with olanzapine was associated with significantly greater improvement at week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. There was no statistically significant difference in mean PANSS total or CGI-S change scores for the lurasidone groups compared with the olanzapine group. With responders defined as those with an improvement of at least 20% on the PANSS, endpoint responder rates were significant compared with placebo for olanzapine only. The incidence of akathisia was higher with 120 mg of lurasidone (22.9%) than with 40 mg of lurasidone (11.8%), olanzapine (7.4%), or placebo (0.9%). The proportion of patients experiencing ≥ 7% weight gain was 5.9% for the lurasidone groups combined, 34.4% for the olanzapine group, and 7.0% for the placebo group.
  
  
  CONCLUSIONS
  Lurasidone was an effective treatment for patients with acute schizophrenia. Safety assessments indicated a higher frequency of adverse events associated with 120 mg/day of lurasidone compared with 40 mg/day.
authors.affiliation: Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, Tenn., USA. herbert.meltzer@vanderbilt.edu
authors.forename: Herbert Y
authors.initials: HY
authors.lastname: Meltzer
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.forename: Robert
authors.initials: R
authors.lastname: Silva
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ogasa
authors.forename: Debra
authors.initials: D
authors.lastname: Phillips
authors.forename: Jane
authors.initials: J
authors.lastname: Xu
authors.forename: Amir H
authors.initials: AH
authors.lastname: Kalali
authors.forename: Edward
authors.initials: E
authors.lastname: Schweizer
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000009:adverse effects / Q000627:therapeutic use*; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D010343:Patient Admission; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D054833:Isoindoles; D013844:Thiazoles; D001569:Benzodiazepines; D000077152:Olanzapine; D000069056:Lurasidone Hydrochloride