title: Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses.
abstract: BACKGROUND
  The efficacy of agents useful for mania is largely unproven in patients with mixed episodes.
  
  
  METHODS
  The efficacy of asenapine in the treatment of mixed episodes was assessed using post hoc analyses on pooled data from two identically designed 3-week, randomized, double-blind, flexible dose, placebo- and olanzapine-controlled trials and their 9-week, double-blind olanzapine-controlled extension study. Efficacy was measured by changes on Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores, and was analysed through analysis of covariance on observed cases of the intent-to-treat dataset.
  
  
  RESULTS
  In the intent-to-treat population, 295 patients had a DSM-IV-TR mixed episode (placebo: 66; olanzapine: 122; asenapine: 107) in the 3-week trials. Of these, 102 patients (olanzapine: 56; asenapine: 46) entered the 9-week extension study. At week 3, decreases in YMRS and MADRS total scores, were significantly (p<0.01) greater with asenapine (YMRS: -15.0; MADRS: -8.2) versus placebo (YMRS: -11.5; MADRS: -4.5); olanzapine did not separate from placebo (YMRS: -13.3; MADRS: -6.5). At week 12, further decreases in YMRS and MADRS total scores were observed with asenapine (YMRS: -22.4; MADRS: -11.9); non-statistically different from olanzapine (YMRS: -20.2; MADRS: -7.9).
  
  
  CONCLUSIONS
  Results are from post hoc analyses of trials that were not designed to specifically evaluate mixed episodes.
  
  
  CONCLUSIONS
  These exploratory analyses provide supportive evidence for the efficacy of asenapine in treating the associated symptoms of mania and depression in bipolar I patients with mixed episodes.
authors.affiliation: Hospital Ste Marguerite, 270 Bd Sainte Marguerite, 13274 Marseille, France. jazorin@ap-hm.fr
authors.forename: J M
authors.initials: JM
authors.lastname: Azorin
authors.forename: C
authors.initials: C
authors.lastname: Sapin
authors.forename: E
authors.initials: E
authors.lastname: Weiller
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D003866:Depressive Disorder / Q000139:chemically induced / Q000188:drug therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D003986:Dibenzocycloheptenes; D004311:Double-Blind Method; D005260:Female; D006576:Heterocyclic Compounds, 4 or More Rings / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic
chemical_list: D014150:Antipsychotic Agents; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings; C522667:asenapine