title: An open-label study of amisulpride in the treatment of mania.
abstract: 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.
authors.affiliation: Bipolar Disorders Program, Hospital Clinic, University of Barcelona, Villaroel 170, 08036 Barcelona, Spain. evieta@clinic.ub.es
authors.forename: Eduard
authors.initials: E
authors.lastname: Vieta
authors.forename: Salvador
authors.initials: S
authors.lastname: Ros
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Goikolea
authors.forename: Antonio
authors.initials: A
authors.lastname: Benabarre
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Popova
authors.forename: Mercè
authors.initials: M
authors.lastname: Comes
authors.forename: Jorge
authors.initials: J
authors.lastname: Capapey
authors.forename: José
authors.initials: J
authors.lastname: Sánchez-Moreno
mesh_terms: 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
chemical_list: D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride