An open non-comparative multicentre study was carried out to evaluate the safety and tolerability of
remoxipride over a treatment period of 12 months. The efficacy of the
drug in controlling psychotic symptoms was also monitored. Eighty-five men and women aged 18-69 who met the Research Diagnostic Criteria for
schizophrenia were entered into the study and after withdrawal of previous
antipsychotic medication, treated orally with
remoxipride 75-300 mg b.i.d. The treatment was well tolerated and most of the adverse symptoms reported were reduced in incidence at the last rating compared to baseline. Sleep problems (
insomnia and increased sleep) and increased thirst showed an increase in incidence during treatment. The incidence of extrapyramidal side effects was low and less than at baseline; there was no evidence that
remoxipride produced an increase in abnormal
involuntary movements, the median weight of the group did not alter and
remoxipride produced no significant effect on cardiovascular, clinical chemistry and haematology variables. It appeared effective in controlling psychotic symptoms and produced some improvement on over one third of the patients despite the fact that the majority of patients entered were not in a productive phase of their illness. The results indicate that
remoxipride will be well tolerated and effective when given for the maintenance treatment of
schizophrenia.