The clinical efficacy of fluspirilene was evaluated in 21 female chronic schizophrenic patients (age range 23-75 years) with a mean duration of hospitalization of 17 years.
After abrupt discontinuation of the previous neuroleptic medication, a weekly intramuscular dose of 2-8 mg of fluspirilene was given for 10 weeks. Patients then entered a 7-week double-blind trial.
Therapeutic assessment was made by a 36- and 7-item rating scale. In two patients fluspirilene treatment was stopped after 5 weeks. In the 19 remaining patients, there was significant improvement in psychotic symptoms, particularly in the areas of motor retardation and mental depression, during the open stage compared with the previous neuroleptic therapy. Significant differences in the incidente and severity of side-effects were not observed.
During the double-blind stage further improvement in psychotic symptoms was noted in fluspirilene-treated patients (10 patients) with statistically significant changes in the areas of mannerisms and posturing and blunted affect. In the placebo-group, antipsychotic effects had markedly decreased (7-item scale).
Extrapyramidal effects occurring in 9 patients were effectively controlled by concomitant injection of the antiparkinsonian agent dexbenzetimide. Blood analyses performed before fluspirilene-treatment and at the end of the open and doubleblind stage revealed no evidente of drug toxicity.