Amisulpride has a superior benefit/risk profile to haloperidol in schizophrenia: results of a multicentre, double-blind study (the Amisulpride Study Group).

In a multicentre, double-blind, flexible-dose study, 199 patients with paranoid schizophrenia or schizophreniform disorders received haloperidol (10-30 mg/d) or amisulpride (400-1200 mg/d) for four months. More patients in the haloperidol group withdrew prematurely (44% vs 26%; P = 0.0077) due to a higher incidence of adverse events. Amisulpride was at least as effective as haloperidol in reducing the Brief Psychiatric Rating Scale (BPRS) total score (-27.3 vs -21.9) (non-inferiority test; P < 0.001). The PANSS positive score improved to a similar extent in both groups whilst improvement in the PANSS negative score was significantly greater with amisulpride (-10.5 vs -7.2; P = 0.01). The percentage of responders on the Clinical Global Impression scale was also significantly greater with amisulpride (71% vs 47%; P < 0.001). Both the Quality of Life Scale (QLS) and the Functional Status Questionnaire (FSQ) improved to a significantly greater extent under amisulpride. Haloperidol was associated with a greater incidence in extrapyramidal symptoms and with a greater increase in the Simpson-Angus score than was seen with amisulpride (0.32 vs 0.02; P < 0.001). In conclusion, amisulpride is globally superior to haloperidol in the treatment of acute exacerbations of schizophrenia and significantly improves patients' quality of life and social adjustment.
AuthorsP Carrière, D Bonhomme, T Lempérière
JournalEuropean psychiatry : the journal of the Association of European Psychiatrists (Eur Psychiatry) Vol. 15 Issue 5 Pg. 321-9 (Aug 2000) ISSN: 0924-9338 [Print] FRANCE
PMID11032464 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antipsychotic Agents
  • Sulpiride
  • sultopride
  • Haloperidol
  • Adolescent
  • Adult
  • Antipsychotic Agents (therapeutic use)
  • Brief Psychiatric Rating Scale
  • Double-Blind Method
  • Female
  • Haloperidol (therapeutic use)
  • Health Status
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Schizophrenia (diagnosis, drug therapy)
  • Sulpiride (analogs & derivatives, therapeutic use)
  • Surveys and Questionnaires
  • Treatment Outcome

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