Efficacy and safety of amisulpride treatment in schizophrenia: Comparison with haloperidol

摘要

Objective: Amisulpride is a novel atypical antipsychotic with preferential affinity for presynaptic dopaminergic D2 and D3 receptors. There have been no clinical studies conducted with amisulpride in schizophrenia in Turkey. The aim of this open-label study was to compare the efficacy and safety of amisulpride and haloperidol in patients with schizophrenia. Methods: Forty patients with schizophrenia according to DSM-IV criteria were included in the study. Patients were randomized to either amisulpride (n=20; 400-800 mg/d) or haloperidol (n=20; 15-30 mg/d) treatment. Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impressions (CGI) were used at days 0, 3, 7, 14, and 28 of treatment. Side effects were recorded on UKU forms. Serum prolactin levels were measured at baseline and at sixth week of treatment. Results: There were no significant differences in terms of improvement of PANSS, BPRS and CGI scores between the groups. While patients on amisulpride had no acute dystonia (p=0.01), and had significantly milder parkinsonism (p<0.05), they had higher weight gain (p=0.001) and serum prolactin increase (p=0.032). Conclusions: In this 6-week trial, amisulpride was as efficacious as haloperidol in treatment of patients with schizophrenia. Extrapyramidal side effects were significantly less common in the amisulpride group.