title: Efficacy of olanzapine monotherapy in the treatment of bipolar depression with mixed features.
abstract: BACKGROUND
  This analysis investigated the correlations between the efficacy of olanzapine monotherapy and the number of concurrent manic symptoms in patients treated for bipolar depression.
  
  
  METHODS
  Pooled data from 2 placebo-controlled olanzapine studies in patients with bipolar I depression were analyzed (total 1214 patients; 690 olanzapine monotherapy patients and 524 placebo patients). Patients were categorized for mixed features by the number of concurrent manic symptoms at baseline (0, 1 or 2, and ≥3, respectively, as measured by a Young Mania Rating Scale item score ≥1). Efficacy was evaluated by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 6 weeks.
  
  
  RESULTS
  Least-squares mean differences between olanzapine and placebo in the change of MADRS total scores were -3.76 (p=0.002), -3.20 (p<0.001), and -3.44 (p=0.002) for mixed features 0, 1 or 2, and ≥3, respectively. The response rates for olanzapine versus (vs.) placebo were 52.6% vs. 39.8%, 50.3% vs. 40.0%, and 42.2% vs. 33.7% for mixed features 0, 1 or 2, and ≥3, respectively. The remission rates for olanzapine vs. placebo group were 46.1% vs. 34.3%, 39.5% vs. 32.0%, and 34.8% vs. 24.1% for mixed features 0, 1 or 2, and ≥3, respectively. No significant interaction between mixed features and treatment was seen in the MADRS changes or response and remission rates.
  
  
  CONCLUSIONS
  Post hoc analyses of the data from 2 previous randomized clinical studies.
  
  
  CONCLUSIONS
  Olanzapine monotherapy was shown to be effective in the treatment of bipolar depression irrespective of the presence of concurrent manic symptoms.
authors.affiliation: University of New Mexico, Health Sciences Center, Department of Psychiatry, Albuquerque, NM, USA.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Tohen
authors.affiliation: Kyushu University, Department of Neuropsychiatry, Fukuoka, Japan; East Asian Bipolar Forum, Fukuoka, Japan.
authors.forename: Shigenobu
authors.initials: S
authors.lastname: Kanba
authors.affiliation: University of Toronto, Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Canada.
authors.forename: Roger S
authors.initials: RS
authors.lastname: McIntyre
authors.affiliation: Eli Lilly Japan K. K., Lilly Research Laboratories, Statistical Science, Kobe, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Fujikoshi
authors.affiliation: Eli Lilly Japan K. K., Lilly Research Laboratories, Medical Science, Kobe, Japan. Electronic address: katagiri_hideaki@lilly.com.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Katagiri
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D006801:Humans; D000077152:Olanzapine; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine
keywords: Bipolar depression; Comorbid manic symptoms; DSM-5; Mixed features; Olanzapine monotherapy