Ziprasidone in the treatment of acute mania: a 12-week, placebo-controlled, haloperidol-referenced study.

Author(s): Vieta E, Ramey T, Keller D, English PA, Loebel AD, Miceli J.

Affiliation(s): Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain. evieta@clinic.ub.es

Publication date & source: 2010, J Psychopharmacol. , 24(4):547-58

This 12-week, double-blind, two-part study in 438 adults with bipolar-associated acute mania began with a 3-week period comparing ziprasidone (80-160 mg/day) and placebo with haloperidol (8-30 mg/day) as active reference. Changes from baseline Mania Rating Scale (MRS) scores for ziprasidone and haloperidol were superior to placebo from day 2 (P = 0.001) to week 3 (P < 0.001); change from baseline at week 3 was greater for haloperidol than ziprasidone (P or=50% decrease from baseline MRS score) was 36.9, 54.7 and 20.5% for ziprasidone, haloperidol and placebo, respectively (P