title: Efficacy of olanzapine in the treatment of bipolar mania with mixed features defined by DSM-5.
abstract: BACKGROUND
  These analyses compared efficacy of olanzapine in patients with bipolar mania with or without mixed features, as defined in the DSM-5.
  
  
  METHODS
  Pooled data from 3 placebo-controlled olanzapine studies in patients having bipolar I disorder with manic/mixed episode were analyzed (N=228 olanzapine; N=219 placebo). Patients were categorized for mixed features by number of concurrent depressive symptoms at baseline (0, 1, and 2 [category A; without mixed features], and ≥3 [category B; with mixed features]), as determined by HAM-D17 item score ≥1. Depressive symptoms corresponded to 6 HAM-D17 items in the DSM-5 definition of manic episode with mixed features. Primary efficacy was evaluated by changes in the baseline-to-3-week YMRS total score.
  
  
  RESULTS
  Patients were categorized into A (N=322; 72.0%) or B (N=125; 28.0%). Mean baseline YMRS total scores were 28.1 in category A and 27.8 in category B. Least-squares mean change of YMRS total scores in categories A and B (olanzapine versus placebo) were -11.78 versus -6.86 and -13.21 versus -4.72, respectively. Patients in the olanzapine- compared with placebo-group experienced a greater decrease in YMRS total score for both categories (p<0.001). An interaction between mixed features and treatment was seen in YMRS change at a 0.3 significance level (p=0.175).
  
  
  CONCLUSIONS
  The results are from post-hoc analyses.
  
  
  CONCLUSIONS
  Olanzapine was efficacious in the treatment of bipolar I mania, in patients both with and without mixed features, defined by DSM-5; however, greater efficacy was observed in patients with mixed features having more severe depressive 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: University of Toronto, Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Canada.
authors.forename: Roger S
authors.initials: RS
authors.lastname: McIntyre
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: 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, Sannomiya Plaza Building, 7-1-5, Isogamidori, Chuo-ku, Kobe 651-0086, Japan. Electronic address: katagiri_hideaki@lilly.com.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Katagiri
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D000077152:Olanzapine; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine
keywords: Bipolar; DSM-5; Mania; Mixed features; Olanzapine