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June 23, 2005

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Amisulpride May Control Mania Symptoms


NEW YORK (Reuters Health) Jun 14 - Amisulpride appears to be a safe and effective treatment for bipolar mania, according to the findings of a small study published in the May issue of the Journal of Clinical Psychiatry.

"Amisulpride is a selective D2-D3 antagonist that has been reported to be effective in the treatment of schizophrenia and major depressive disorder," Dr. Eduard Vieta, of the University of Barcelona, and colleagues write. "However, no prospective study to date has assessed the effectiveness and tolerability of this compound in mania."

In an open, prospective, 6-week study, the researchers examined the safety and efficacy of amisulpride in 20 acutely manic patients with a Young Mania Rating Scale (YMRS) score of at least 20.

Efficacy measures included the YMRS, the Hamilton Rating Scale for Depression (HAM-D), and the Clinical Global Impressions Scale for Bipolar Disorder, Modified (CGI-BP-M). Adverse events were systematically assessed at week 1, 2, and 6.

A total of 14 patients completed the study. Two patients withdrew due to lack of efficacy and two due to side effects. Another patient decided to withdraw and the sixth patient was lost to follow-up.

In the follow-up analysis, amisulpride treatment resulted in significant improvements on the YMRS (p = 0.0001) and the HAM-D (p = 0.0141). Significant improvements were also observed in the CGI-BP-M overall subscale, mania subscale, and depression subscale.

Thirteen of the 14 patients "were considered responders, as they achieved at least 50% improvement in their baseline YMRS scores," Dr. Vieta's team writes. "Remission was achieved by 10 patients," they note.

The most common side effects were sedation and dry mouth. Other symptoms included tremor, dystonia, and akathisia.

Based on these findings, the investigators conclude that "controlled trials are warranted" and that "D2/D3 antagonism may be a relevant mechanism in the pathophysiology of the response to treatment in mania."

J Clin Psychiatry 2005;66:575-578.



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