A double‐blind multicentre study comparing remoxipride, two and three times daily, with haloperidol in schizophrenia

Abstract

A double-blind multicentre study comparing the efficacy and safety of remoxipride in relation to haloperidol was conducted in 160 inpatients with schizophrenic illness diagnosed according to DSM-III. The study period was 4 weeks. The mean daily dose of remoxipride (whether given twice or three times daily) during the last week of treatment was 395 mg; the corresponding dose of haloperidol was 17 mg per day. No significant difference in therapeutic efficacy was found; Brief Psychiatric Rating Scale (BPRS) median total scores dropped from 41 to 20 (remoxipride twice daily, n = 51), 43 to 20 (remoxipride three times daily, n = 44) 40 to 19 (haloperidol three times daily, n = 48) at last valid rating. According to Clinical Global Impression (CGI) 68% in the remoxipride twice daily, 58% in the three times daily and 60% in the haloperidol group were very much or much improved. Treatment-emergent extrapyramidal checklist symptoms (hypokinesia, rigidity and tremor) were statistically significantly more frequent and more severe during haloperidol than during remoxipride treatment despite a statistically significantly higher concurrent use of anticholinergic drugs in the haloperidol group. Haloperidol treated patients reported more tiredness and drowsiness than remoxipride treated patients. Also, haloperidol treated patients had a significantly higher frequency of extrapyramidal symptoms on 8 out of 10 items of the Simpson and Angus scale.