title: Olanzapine versus placebo in acute mania: treatment responses in subgroups.
abstract: Two double-blind, placebo-controlled trials of olanzapine in acute mania showed significant overall antimanic efficacy, based on reductions in mania ratings. Their subject-level data were pooled to increase statistical power to test for differences in treatment responses among 10 subgroup pairs of interest using generalized estimating equations methods. Similar drug/placebo superiority and responsiveness to olanzapine was found in men versus women, psychotic versus nonpsychotic subjects, and those presenting in mania versus mixed states, and responses were independent of onset age, current age, or prior illness based on episodes, hospitalizations, recent rapid cycling, lifetime substance use, or previous antipsychotic treatment. Olanzapine and placebo responses paralleled closely (r(s) = 0.73). Patients were relatively more responsive to olanzapine who were younger at illness onset, lacked prior substance abuse, and had not previously received antipsychotic treatment (efficacy ratios 1.5-1.7, all P < 0.01). These well-powered comparisons of subgroups of interest indicate broad efficacy of olanzapine in the treatment of acute mania.
authors.affiliation: International Consortium for Bipolar Disorder Research, Department of Psychiatry and Neuroscience Program, Harvard Medical School, Boston, MA, USA. rjb@mclean.org
authors.forename: Ross J
authors.initials: RJ
authors.lastname: Baldessarini
authors.forename: John
authors.initials: J
authors.lastname: Hennen
authors.forename: Michael
authors.initials: M
authors.lastname: Wilson
authors.forename: Joseph
authors.initials: J
authors.lastname: Calabrese
authors.forename: Roy
authors.initials: R
authors.lastname: Chengappa
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.forename: Gary
authors.initials: G
authors.lastname: Sachs
authors.forename: Eduard
authors.initials: E
authors.lastname: Vieta
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Welge
authors.forename: Lakshmi N
authors.initials: LN
authors.lastname: Yatham
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Zarate
authors.forename: Robert W
authors.initials: RW
authors.lastname: Baker
authors.forename: Mauricio
authors.initials: M
authors.lastname: Tohen
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D000077152:Olanzapine; D010890:Pirenzepine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012306:Risk
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D010890:Pirenzepine; D000077152:Olanzapine