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.
Carrière
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Service Médico-Psychologique Régional, BP 549, Châteauroux, France.
Bonhomme
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Lempérière
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D000293:Adolescent; D000328:Adult; D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride; D006220:Haloperidol