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.
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Authors | S Stahl, I Lombardo, A Loebel, F S Mandel |
Journal | Journal of affective disorders
(J Affect Disord)
Vol. 122
Issue 1-2
Pg. 39-45
(Apr 2010)
ISSN: 1573-2517 [Electronic] Netherlands |
PMID | 19616304
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2009 Elsevier B.V. All rights reserved. |
Chemical References |
- Piperazines
- Thiazoles
- ziprasidone
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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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