title: Safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania: a 12-week open-label study.
abstract: OBJECTIVE
  To examine the safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania.
  
  
  METHODS
  Subjects (n = 18) who were acutely manic, did not respond to lithium, anticonvulsants, and neuroleptics, and/or had intolerable side effects to them in previous manic episodes were openly treated with olanzapine monotherapy (5-40 mg/d) for 12 weeks. The primary and secondary outcomes included the change from baseline to endpoint in Young Mania Rating Scale (YMRS) total score, Clinical Global Impression for Bipolar Disorder-Severity Scale (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D) and Positive and Negative Syndrome Scale (PANSS), and response and remission rate.
  
  
  RESULTS
  The mean change in YMRS total score from baseline to endpoint was -23.3 ± 8.4 (p < 0.001). Fifteen (88.5%) patients achieved response (≥50% reduction in YMRS total score) and 14 (77.8%) achieved remission (YMRS total score ≤9 at endpoint). Mean changes from baseline to endpoint in CGI-S for mania and PANSS total score were significant, but not the changes in HAM-D total score or CGI-S for depression. The most common adverse events were sedation, self-reported weight gain, ≥7% increase in body weight, dizziness, and akathisia.
  
  
  CONCLUSIONS
  These preliminary results suggest that olanzapine monotherapy is effective and relatively safe in patients with treatment-resistant bipolar mania. Randomized, double-blind, placebo-controlled study is warranted.
authors.affiliation: Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Chen
authors.forename: David J
authors.initials: DJ
authors.lastname: Muzina
authors.forename: David E
authors.initials: DE
authors.lastname: Kemp
authors.forename: Carla
authors.initials: C
authors.lastname: Conroy
authors.forename: Philip
authors.initials: P
authors.lastname: Chan
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Serrano
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Ganocy
authors.forename: Yiru
authors.initials: Y
authors.lastname: Fang
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Calabrese
authors.forename: Keming
authors.initials: K
authors.lastname: Gao
mesh_terms: D000328:Adult; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001569:Benzodiazepines; D000077152:Olanzapine