title: LURASIDONE IN THE LONG-TERM TREATMENT OF PATIENTS WITH BIPOLAR DISORDER: A 24-WEEK OPEN-LABEL EXTENSION STUDY.
abstract: The aim of this study was to evaluate the safety and tolerability of 6 months of open-label, uncontrolled extension treatment with lurasidone in patients with a diagnosis of bipolar depression who completed 6 weeks of acute treatment.
  
  
  
  Patients completing 6 weeks of double-blind placebo-controlled treatment with either lurasidone monotherapy (one study) or adjunctive therapy with lithium or valproate (two studies), were treated for 6 months with flexible doses of lurasidone, 20-120 mg/day, in an open-label, uncontrolled extension study (N = 813; monotherapy, 38.9%; adjunctive therapy, 61.1%). Changes in safety parameters were calculated from double-blind, acute-phase baseline to month 6 of the extension phase, using a last observation carried forward (LOCF endpoint) analysis.
  
  
  
  Five hundred fifty-nine of 817 (68.4%) patients completed the extension study. In the monotherapy and adjunctive therapy groups, 6.9 and 9.0%, respectively, discontinued due to an adverse event. For the monotherapy and adjunctive therapy groups, respectively, changes from double-blind baseline to month 6 were +0.8 and +0.9 kg for weight (mean), 0.0 and +2.0 mg/dL for total cholesterol (median), +5.0 and +5.0 mg/dL for triglycerides (median), -1.0 and 0.0 mg/dL for glucose (median); -22.6 and -21.7 for Montgomery-Asberg Depression Rating Scale (MADRS; mean); whereas change from open-label baseline to month 6 were +0.85 and +0.88 kg for weight (mean), and -6.9 and -6.5 for MADRS (mean).
  
  
  
  Six months of treatment with open-label lurasidone was safe and well tolerated with minimal effect on weight and metabolic parameters; continued improvement in depressive symptoms was observed.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.
authors.forename: Terence A
authors.initials: TA
authors.lastname: Ketter
authors.affiliation: Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey and Marlborough, Massachusetts.
authors.forename: Kaushik
authors.initials: K
authors.lastname: Sarma
authors.affiliation: Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey and Marlborough, Massachusetts.
authors.forename: Robert
authors.initials: R
authors.lastname: Silva
authors.affiliation: Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey and Marlborough, Massachusetts.
authors.forename: Hans
authors.initials: H
authors.lastname: Kroger
authors.affiliation: Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey and Marlborough, Massachusetts.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey and Marlborough, Massachusetts.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000627:therapeutic use; D000069056:Lurasidone Hydrochloride / Q000627:therapeutic use*; D008297:Male; D013995:Time; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage
chemical_list: D014150:Antipsychotic Agents; D018020:Lithium Compounds; D014635:Valproic Acid; D000069056:Lurasidone Hydrochloride
keywords: antipsychotic agents; bipolar depression; bipolar disorder; depressive disorder; lithium; lurasidone; major depression; valproate