P0110 - Efficacy of Ziprasidone in hospitalized patients with severe mania

Abstract

Background:

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

Methods:

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.

Results:

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.

Conclusions:

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.