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

Abstract 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 P  = 0.01). The percentage of responders on the Clinical Global Impression scale was also significantly greater with amisulpride (71% vs 47%; P P