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,"
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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