An Open-Label Study of Amisulpride in the Treatment of Mania
J Clin Psychiatry 2005;66(5):575-578
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Amisulpride is a selective D2-D3 antagonist that has been reported to be effective in the
treatment of schizophrenia and major depressive disorder.
However, no prospective study to date has assessed the
effectiveness and tolerability of this compound in mania.
Method: Twenty DSM-IV-defined acutely ill
manic bipolar patients with a Young Mania Rating Scale (YMRS)
score of 20 or more entered this open, prospective, 6-week study.
Assessments included the YMRS, the Hamilton Rating Scale for
Depression (HAM-D), the Clinical Global Impressions Scale for
Bipolar Disorder, Modified (CGI-BP-M), and the systematic report
of adverse events. Amisulpride was added to other medications,
but other antipsychotics were not allowed.
Results: Fourteen patients (70%)
completed the study. Using last-observation-carried-forward
(LOCF) analyses, amisulpride produced significant improvements on
the YMRS (p = .0001), the HAM-D (p < .0141), and the overall
(p = .0003), mania (p = .0001), and depression (p = .0268) subscales of
the CGI-BP-M. The most common side effect was sedation (N = 5,
25%), but there were also some extrapyramidal symptoms,
galactorrhea, insomnia, and agitation. The mean amisulpride dose
was 680 mg/day (LOCF) and 786 mg/day in completers.
Conclusions: This first prospective study on
amisulpride in the treatment of mania suggests that, despite the
limitations of the open, observational design and small sample
size, amisulpride may be effective and reasonably safe in the
treatment of bipolar mania. D2 and D3 antagonism may be involved in the mechanisms of the therapeutic
response to antipsychotics in mania.