In a double-blind multicentre study of parallel group design the efficacy and safety of
remoxipride and
haloperidol were compared in a total of 96 patients with acute episodes of schizophrenic or
schizophreniform disorder according to DSM-III. There were 48 patients in each treatment group; 27 men and 21 women in the
remoxipride group, 33 men and 15 women in the
haloperidol group. The median duration of illness was 7 years in both groups. The mean daily dose was 437 mg for
remoxipride and 10.6 mg for
haloperidol during the last week of treatment. No statistically significant differences in total BPRS scores were found between
remoxipride and
haloperidol. The median total BPRS scores at the start of active treatment were 26 in the
remoxipride and 27 in the
haloperidol group; these were reduced to 16 and 12.5, respectively, at the last rating. According to Clinical Global Impression (CGI), 43% of patients in the
remoxipride group and 68% of those in the
haloperidol group improved much or very much during treatment. This difference was not statistically significant. Treatment-emergent extrapyramidal side effects such as
akathisia,
tremor, and rigidity occurred significantly more frequently in the
haloperidol group; this group also made more frequent use of
anticholinergic drugs. Neither of the trial drugs seriously affected laboratory or cardiovascular variables. It is concluded that
remoxipride has an
antipsychotic effect in a dose range of 150-600 mg per day comparable to that of
haloperidol in doses up to 20 mg per day but with fewer extrapyramidal side effects.