An open-label study of amisulpride in the treatment of mania.
BACKGROUND
Amisulpride is a selective D(2)-D(3) 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.


METHODS
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. D(2) and D(3) antagonism may be involved in the mechanisms of the therapeutic response to antipsychotics in mania.
Vieta
Eduard
E
Bipolar Disorders Program, Hospital Clinic, University of Barcelona, Villaroel 170, 08036 Barcelona, Spain. evieta@clinic.ub.es
Ros
Salvador
S
Goikolea
José Manuel
JM
Benabarre
Antonio
A
Popova
Ekaterina
E
Comes
Mercè
M
Capapey
Jorge
J
Sánchez-Moreno
José
J
D000328:Adult; D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride