title: Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study.
abstract: OBJECTIVE
  The primary objective was to evaluate the safety and tolerability of lurasidone, a new atypical antipsychotic agent, in the longer-term treatment of schizophrenia (DSM-IV). Persistence of symptom improvement was assessed as a secondary outcome.
  
  
  METHODS
  Patients who completed a 6-week, double-blind, placebo-controlled study evaluating the efficacy of fixed doses of once-daily lurasidone (40 or 120 mg) or olanzapine 15 mg (to confirm assay sensitivity) were eligible to receive flexibly dosed lurasidone 40 to 120 mg/d in this 6-month, open-label extension study (conducted from March 2008 to December 2009). Assessments of safety and tolerability were conducted at open-label baseline, at day 10, and monthly thereafter.
  
  
  RESULTS
  Of 254 enrolled patients, 113 (44.5%) completed 6 months of open-label treatment. During the open-label study (month 6 observed cases), small decreases were observed in mean weight (-0.1 kg) and median lipid levels (total cholesterol, -6.5 mg/dL; low-density lipoprotein, 0.0 mg/dL; high-density lipoprotein, 0.0 mg/dL; triglycerides, -8.5 mg/dL). Patients previously treated with olanzapine (n = 69) experienced decrease in weight and improvement in lipid levels, whereas patients previously treated with lurasidone (n = 115) or placebo (n = 62) experienced minimal changes. No clinically meaningful changes were observed in median prolactin levels. The 2 most commonly reported adverse events were akathisia (13.0%) and insomnia (11.0%). Persistent antipsychotic efficacy of lurasidone was shown for patients who had previously received lurasidone, olanzapine, or placebo; further reductions from open-label baseline to final visit were observed in mean PANSS total score (-8.7) for all patients.
  
  
  CONCLUSIONS
  Open-label treatment with flexibly dosed lurasidone (40-120 mg/d) was generally safe, well tolerated, and effective over a 6-month period in patients who had completed a preceding 6-week, double-blind study.
authors.affiliation: Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, USA. smstahl@neiglobal.com
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Stahl
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.forename: Doreen
authors.initials: D
authors.lastname: Simonelli
authors.forename: Jay
authors.initials: J
authors.lastname: Hsu
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001569:Benzodiazepines / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000069056:Lurasidone Hydrochloride; D008297:Male; D000077152:Olanzapine; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D054833:Isoindoles; D010919:Placebos; D013844:Thiazoles; D001569:Benzodiazepines; D000077152:Olanzapine; D000069056:Lurasidone Hydrochloride