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

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 ≤ 0.001). At week 3, the response rate (≥50% decrease from baseline MRS score) was 36.9, 54.7 and 20.5% for ziprasidone, haloperidol and placebo, respectively (P ≤ 0.05, active treatments versus placebo and ziprasidone versus haloperidol). In the 9-week extension phase, ziprasidone replaced placebo to examine tolerability. Maintenance of improvement was evaluated for ziprasidone (40—160 mg/day) or haloperidol (4—30 mg/day). Responses were maintained through the last visit for 88.1% receiving ziprasidone and 96.3% receiving haloperidol. More patients receiv...