Ziprasidone is effective and well tolerated in patients with bipolar mania, as demonstrated by 2 pivotal, placebo-controlled trials.

We evaluated pooled data for subjects with baseline Mania Rating Scale (MRS) scores in the highest 10% of the severity distribution at study baseline. All subjects in this post hoc analysis had an MRS score ≥ 36, indicating marked severity of mania. Changes in MRS scores from baseline to days 2, 4, 7, 14, and 21 were analyzed using a Cochran-Mantel-Haenszel test to determine response, defined as a decrease in MRS score of ≥ 50% from baseline, and remission, defined as an MRS score ≤ 10.

The proportion of subjects achieving response was significantly greater for subjects receiving ziprasidone compared with placebo from day 7 (p = 0.03) through to study end point (p < 0.001). The proportion of subjects achieving remission was significantly greater than placebo (p = 0.01) at study end point. Few subjects who received placebo achieved response, and none achieved remission at any timepoint during the study.

Ziprasidone is effective in the treatment of patients with severe manic symptoms. This conclusion is underscored by the relatively large drug-placebo differences observed in this patient subsample.