title: Lurasidone for major depressive disorder with mixed features and anxiety: a post-hoc analysis of a randomized, placebo-controlled study.
abstract: OBJECTIVE
  The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety.
  
  
  METHODS
  The data in this analysis were derived from a study of patients meeting the DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM-A≤14) and moderate-to-severe anxiety (HAM-A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures.
  
  
  RESULTS
  Treatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (-18.4 vs. -12.8, p<0.01, effect size [ES]=0.59) and moderate-to-severe anxiety (-22.0 vs. -13.0, p<0.001, ES=0.95). Treatment with lurasidone was associated with a significant week 6 change versus placebo in HAM-A total score for patients with both mild anxiety (-7.6 vs. -4.0, p<0.01, ES=0.62), and moderate-to-severe anxiety (-11.4 vs. -6.1, p<0.0001, ES=0.91).
  
  
  CONCLUSIONS
  In this post-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.
authors.affiliation: 1Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,and Marlborough,Massachusetts,USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Tsai
authors.affiliation: 2Perelman School of Medicine of the University of Pennsylvania,Philadelphia,Pennsylvania,USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.affiliation: 1Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,and Marlborough,Massachusetts,USA.
authors.forename: Yongcai
authors.initials: Y
authors.lastname: Mao
authors.affiliation: 1Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,and Marlborough,Massachusetts,USA.
authors.forename: Daisy
authors.initials: D
authors.lastname: Ng-Mak
authors.affiliation: 1Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,and Marlborough,Massachusetts,USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: 1Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,and Marlborough,Massachusetts,USA.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D000374:Aggression / Q000187:drug effects / Q000523:psychology; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069056:Lurasidone Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000066553:Problem Behavior / Q000523:psychology; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011594:Psychometrics; D016896:Treatment Outcome
chemical_list: D000069056:Lurasidone Hydrochloride
keywords: Major depressive disorder; anxiety; atypical antipsychotic; lurasidone; mixed features