Efficacy of ziprasidone in dysphoric mania: Pooled analysis of two double-blind studies

Abstract 

Background

Dysphoric mania is a common and often difficult to treat subset of bipolar mania that is associated with significant depressive symptoms.

Objective

This post hoc analysis was designed to evaluate the efficacy of ziprasidone in the treatment of depressive and other symptoms in a cohort of patients with dysphoric mania.

Methods

Pooled data were examined from two similarly designed, 3-week placebo-controlled trials in acute bipolar mania. Patients scoring ≥2 on at least two items of the extracted Hamilton Rating Scale for Depression (HAM-D) met criteria for dysphoric mania and were included in the post hoc analysis. Changes from baseline in symptom scores were evaluated by a mixed-model analysis of covariance.

Results

179 patients with dysphoric mania were included in the post hoc analysis (ziprasidone, n=124; placebo, n=55). Beginning at day 4, HAM-D scores were significantly lower at all visits in patients treated with ziprasidone compared with those treated with placebo (p<0.05). Ziprasidone-treated patients also demonstrated significant improvements on the Mania Rating Scale and all secondary efficacy measures, and had significantly higher response and remission rates compared with placebo.

Limitations

The main limitations are the use of a post hoc analysis and the pooling of two studies with slightly different designs.

Conclusion

In this analysis, ziprasidone significantly improved both depressive and manic mood symptoms in patients with dysphoric mania, suggesting that it might be a useful treatment option in this patient population. Further prospective controlled trials are needed to confirm these findings.

Keywords: Dysphoric mania, Dysphoria, Bipolar mania, Mixed mania, Ziprasidone