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


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


CONCLUSIONS
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.
Stahl
S
S
Department of Psychiatry, UCSD, San Diego, CA 92008, USA. smstahl@neiglobal.com
Lombardo
I
I
Loebel
A
A
Mandel
F S
FS
D000208:Acute Disease; D000328:Adult; D000339:Affect / Q000187:drug effects; D000368:Aged; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*
D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone