The efficacy and safety of amisulpride in the treatment of acute exacerbation patients with schizophrenia

Objective To evaluate the efficacy and safety of amisulpride in acute exacerbation patients with schizophrenia. Methods In this study, one hundred and forty-four acute episode patients with schizophrenia, qualifyed with the International Classification of Diseases 10th revision, were enrolled. All patients received monotherapy of amisulpride for 8 weeks. The initial dose of amisulpride was 200 mg/d, and the dose was flexible during the 8 weeks according to the investigator judgement based upon symptoms and tolerability. Recommended therapeutic dose was 800 mg/d and maximum dose was 1 200 mg/d. The Positive and Negative Syndrome Scale (PANSS) was applied at the baseline and the 2nd, 4th, 8th week.The Clinical Global Impression Scale-Severity and Improvement (CGI-S, CGI-I) and the Personal and Social performance Scale (PSP) were adopted at the baseline and endpoint of treatment. The safety was evaluated by the Udvalg for Kliniske Undersogeser Side Effect Rating Scale, laboratory tests and electrocardiogram. The efficacy and safety were analyzed by using perprotocol and safety sets respectively. Results One hundred and thirty two patients completed this trial,and 12 patients dropped out during the study. After 8-week treatment, the positive scores (22.0±6.6 vs. 10.0±3.8) , negative scores (22.7±7.7 vs. 13.9±6.8) , general psychopathology scores (41.6±9.0 vs. 25.1±7.4) and the total scores (86.5±16.0 vs. 49.0±16.0) of PANSS were significantly improved (P<0.01) ; 77.3% patients had symptoms reduced in PANSS total scores by at least 50%, and the result was accordant to significant CGI-I improvement in 75.8% patients. Besides these, the PANSS response rate was significantly higher in positive scores than in negative scores (χ2=9.52, P<0.01). PSP was also significantly improved after 8-week treatment (t=18.10, P<0.01). The most popular side effects were extrapyramidal symptoms(29.2%) and hyperprolactinemia(23.6%). Conclusions Amisulpride is effective in treating psychopathological symptoms of acute exacerbations patients with schizophrenia, the most frequent side effects are seen in extrapyramidal symptoms and hyperprolactinemia. Key words: Schizophrenia; Safety; Treatment outcome; Amisulpride