Efficacy and Safety of the Domestic Risperidone in Patients with Schizophrenia:a Randomized,Double-blind,Controlled Trial

Objective:To evaluate the efficacy and safety of domestic risperidone in the treatment of schizophrenia.Methods:A randomized,double-blind,controlled multicenter clinical trial was conducted.All 214 outpatients or inpatients who met criteria for schizophrenia in the Chinese Classification and Diagnostic Criteria of Mental Disorders Third Edition were randomly assigned to domestic(n=107) or import risperidone(n=107) treatment for 8 weeks,and the averaged dosage was 3.9 mg/d and 3.7 mg/d respectively.The efficacy was evaluated with the Positive and Negative Symptoms Scale(PANSS) and Clinical Global Impression Scale(CGI).The safety and tolerability were assessed with the Treatment Emergent Symptom Scale(TESS),biochemical index,electrocardiogram and weight gain.Results:The response rates were 76% and 68.6% in domestic risperidone and import risperidone group respectively.The positive,negative and general psychopathological symptoms were significantly improved(P0.05) after 8 week treatment in the two groups,there were no significant differences on reducing score rate of PANSS total scores between the two groups.Incidence of adverse events was 40% in domestic risperidone and 37.1% in import risperidone group.Both medications caused substantial rapid weight gain(P0.01),and the TESS total score of domestic risperidone was significantly lower than that of import risperidone(P0.01).Conclusion:The results show that domestic risperidone has similar therapeutic effect to import risperidone in treatment of schizophrenia,and is safe and generally well-tolerated.