A double-blind multicentre study comparing remoxipride, controlled release formulation, with haloperidol in schizophrenia.

Abstract

A double-blind multicentre study was undertaken to compare the efficacy and safety of remoxipride in a controlled release (CR) formulation given once daily with haloperidol twice daily in patients with schizophrenic illness. In total, 114 patients were included. All were diagnosed as schizophrenic or schizophreniform according to DSM-III. Their mean daily dose of remoxipride CR during the last week of treatment was 385 mg. In the haloperidol group the corresponding dose was 17 mg per day. The intended study period was 4 weeks with at least a one-day washout. No significant differences were found between treatments regarding efficacy variables. The median total Brief Psychiatric Rating Scale (BPRS) score was 40 in the remoxipride CR group at start of treatment and 21 at last valid rating. For the haloperidol group the corresponding figures were 40 and 22. Treatment-emergent extrapyramidal symptoms (Simpson and Angus rating) occurred statistically significantly more frequently and were more severe during haloperidol than during remoxipride CR treatment despite a statistically significantly higher concurrent use of anticholinergic drugs in the haloperidol group.