title: Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies.
abstract: OBJECTIVE
  The aim of this post hoc analysis was to evaluate the efficacy of lurasidone in patients aged 55 years and older with bipolar depression.
  
  
  METHODS
  A post hoc analysis was performed on the older adult subgroup (n = 142) of outpatients meeting DSM-IV-TR criteria for bipolar I depression in 2 placebo-controlled, 6-week, randomized, double-blind studies conducted from 2009-2012: a monotherapy study comparing fixed flexible-dose ranges of lurasidone 20-60 mg/d or 80-120 mg/d with placebo and an adjunctive therapy study comparing flexible doses of lurasidone 20-120 mg/d with placebo adjunctive to either lithium or valproate. The primary endpoint was mean change at week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
  
  
  RESULTS
  In the randomized sample, the proportion of older adults was 88/505 (17.4%) in the monotherapy study and 54/348 (15.5%) in the adjunctive therapy study. In the older adult subgroup in the monotherapy study, mean change at week 6 in the MADRS was significantly greater for lurasidone versus placebo (-14.8 vs -7.1; P = .003; effect size, 0.83; pooled doses), and in the adjunctive therapy study, mean change for lurasidone was not significantly different from placebo (-13.9 vs -11.1; P = .398; effect size, 0.26). Discontinuation rates due to adverse events for lurasidone versus placebo were similar for the monotherapy (6.8% vs 6.9%) and adjunctive therapy (3.8% vs 7.1%) studies. Lurasidone had minimal effects on metabolic laboratory values.
  
  
  CONCLUSIONS
  The results of these post hoc analyses, which assessed the efficacy of lurasidone in older adults with bipolar disorder, found that monotherapy was significantly effective while adjunctive therapy was not associated with significant improvement. Both monotherapy and adjunctive therapy with lurasidone were safe and well-tolerated in this older adult population.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT00868699, NCT00868452.
authors.affiliation: Department of Psychiatry, University Hospitals Case Medical Center, 10524 Euclid Ave, Cleveland, OH 44106. martha.sajatovic@uhhospitals.org.|Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
authors.forename: Martha
authors.initials: M
authors.lastname: Sajatovic
authors.affiliation: Harvard Medical School, Boston, Massachusetts; and McLean Hospital, Belmont, Massachusetts, USA.
authors.forename: Brent P
authors.initials: BP
authors.lastname: Forester
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts and Fort Lee, New Jersey, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Tsai
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts and Fort Lee, New Jersey, USA.
authors.forename: Hans
authors.initials: H
authors.lastname: Kroger
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts and Fort Lee, New Jersey, USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts and Fort Lee, New Jersey, USA.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts and Fort Lee, New Jersey, USA.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000368:Aged; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000627:therapeutic use; D000069056:Lurasidone Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014635:Valproic Acid / Q000627:therapeutic use*
chemical_list: D016651:Lithium Carbonate; D014635:Valproic Acid; D000069056:Lurasidone Hydrochloride