Ziprasidone in bipolar mania: efficacy across patient subgroups

Study objectives: We evaluate the efficacy and tolerability of ziprasidone in acute bipolar mania, focusing on clinically relevant subgroups. Methods: This was a pooled analysis of 2 randomized, double-blind, 21-day trials comparing flexible-dose ziprasidone (40 to 80 mg twice daily) with placebo in adults with mania associated with bipolar I disorder. Changes in Mania Rating Scale (MRS) score and Clinical Global Impression of Severity (CGI–S) were calculated for combined study populations and in subgroups of patients with manic episodes, mixed episodes, and with or without psychotic symptoms. Results: At last visit, mean change in MRS score in patients receiving ziprasidone (n=268) was −11.72 (baseline 26.82) versus −6.69 (baseline 26.53) in patients receiving placebo (n=131; P<.001). Change in CGI–S for ziprasidone was −1.19 (baseline 4.71) versus −0.66 (baseline 4.76) for placebo (P<.001). Significant improvement versus placebo was observed from day 2 for MRS score and day 4 for CGI–S. MRS score and CGI–S changes were comparably robust whether patientsʹ manic episode was classified as acute or mixed or was complicated by psychotic symptoms or not. Overall, ziprasidone subjects had a response rate of 48% and a remission rate of 40% (both P<.01 versus placebo). Conclusion: Ziprasidone rapidly improves symptoms and global illness severity in bipolar mania. It is comparably efficacious in mixed and manic episodes and in the presence or absence of psychotic symptoms and is well tolerated.