title: Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study.
abstract: BACKGROUND
  In this post-hoc analysis, rates of remission and recovery were evaluated in patients with bipolar depression treated with lurasidone.
  
  
  METHODS
  Outpatients meeting DSM-IV-TR criteria for bipolar I depression, were randomized to 6 weeks of once-daily, double-blind treatment with lurasidone 20-60mg, lurasidone 80-120mg or placebo, followed by a 6-month, open-label, flexible-dose, lurasidone continuation study. Recovery was defined as meeting criteria for combined symptomatic remission (Montgomery-Asberg Depression Rating Scale total score ≤12) and functional remission (all Sheehan Disability Scale domain scores ≤3) sustained for at least 3 months in the 6-month continuation study.
  
  
  RESULTS
  A significantly higher proportion of lurasidone-treated patients met criteria for combined symptomatic remission and functional remission (33.3%, 91/273) compared to the placebo group (21.0%, 30/143, p<0.05, NNT=9) at the 6-week study endpoint. In the 6-month continuation study, the proportion of lurasidone-treated patients achieving sustained recovery was 60.7% (85/140) and 44.9% (31/69), for patients who continued lurasidone treatment and who switched from placebo to lurasidone, respectively.
  
  
  CONCLUSIONS
  The definition of recovery used has not been previously validated and the analysis was post hoc. Lack of a control group in the continuation study limits data interpretation.
  
  
  CONCLUSIONS
  Recovery in patients with bipolar depression was assessed based on rates of combined symptomatic and functional remission sustained over time. A majority of patients initially treated with lurasidone in the acute phase achieved recovery status in the continuation study. Treatment with lurasidone (vs. placebo) earlier in the course of the bipolar depressive episode increased the likelihood of subsequent recovery.
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA , USA; Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA. Electronic address: antony.loebel@sunovion.com.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
authors.affiliation: COS and Associates Ltd., Hong Kong, Hong Kong.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Siu
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA , USA; Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.
authors.forename: Krithika
authors.initials: K
authors.lastname: Rajagopalan
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA , USA; Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA , USA; Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Terence A
authors.initials: TA
authors.lastname: Ketter
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D000069056:Lurasidone Hydrochloride / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D013995:Time; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000069056:Lurasidone Hydrochloride
keywords: Bipolar depression; Functional remission; Lurasidone; Recovery; Symptomatic remission