A single-blind comparative study was performed using haloperidol as a reference drug in order to evaluate the efficacy and safety of nemonapride, a new benzamide derivative, in sixty-nine Korean schizophrenic patients. the total period of the study was 8 weeks, maximum dosage of nemonapride was 36mg and that of haloperidol was 24mg.
Psychopathology and extrapyramidal symotoms were assessed every week or four weeks until the end of the 8th week using the PANSS, BPRS, and 4 point general side effect check list, The drug safety was assessed every week until the end of the 8th week using vital sign, body weight, EEG, EKG, and blood chemistry. In total, one patient discontinued nemonapride treatment and seven patients discontinued haloperidol treatment before the end of the study. Therefore sixty-one patients(88 %) completed the study.
PNASS and BPRS scores of the two groups on the end study point demonstrated a significant improvement compared with baseline´ score. The number of patients who had a clinical improvement of at least 20% in baseline score was similiar in both treatment groups. The difference of Simpson´s rating scale socres were significant in both groups, and mean scores were more high in the haloperidol group than in nemonapride group.
No significant EKG, EEG changes were induced, no relevant change in body weight or clinical laboratory parameters were observed in the sixty-one patients during 8 weeks and no significant difference in the both groups. From these results, nemonapride is considered to be a clinically useful drug having a wide range of antipsychotic effect in schzophrenic patients.
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