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

AbstractBACKGROUND:
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.
AuthorsS Stahl, I Lombardo, A Loebel, F S Mandel
JournalJournal of affective disorders (J Affect Disord) Vol. 122 Issue 1-2 Pg. 39-45 (Apr 2010) ISSN: 1573-2517 [Electronic] Netherlands
PMID19616304 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2009 Elsevier B.V. All rights reserved.
Chemical References
  • Piperazines
  • Thiazoles
  • ziprasidone
Topics
  • Acute Disease
  • Adult
  • Affect (drug effects)
  • Aged
  • Bipolar Disorder (diagnosis, drug therapy, psychology)
  • Depression (diagnosis, drug therapy, psychology)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Piperazines (adverse effects, therapeutic use)
  • Psychiatric Status Rating Scales
  • Thiazoles (adverse effects, therapeutic use)

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