Comparison Of Effect Of Addition Of Fluvoxamine Or Risperidone To Clozapine In Chronic Partially Responsive Schizophrenic Patients On Clinical Response, QTc interval And Lipid profile

Sunil M. Mahakalkar, D. Patil, P. Waradkar, Chetan S. Urade, C. Bajait
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Abstract

Objective To study & compare the augmentation effect of addition of fluvoxamine or risperidone in chronic partially responsive schizophrenic patients receiving clozapine on clinical and laboratory parameters. Methods - A prospective, randomized, parallel, open label 12 weeks study. The schizophrenic patients, aged 20-60 years, who followed the DSM-IV diagnostic criteria and receiving clozapine therapy, showing partial response to the treatment were recruited and the study was carried out from January 2007 to June 2008. Subjects were randomized into two groups: Group A (n=28): fluvoxamine (25-50mg/day) was added to clozapine (25-200mg/day) & Group B (n=27): risperidone (1-5mg/day) was added to clozapine therapy. The effect of drugs was assessed by PANSS, BPRS scale and ECG and lipid profile were done at 6 and 12 weeks. Result - There was significant decrease in PANSS and BPRS score in both groups. Fluvoxamine + clozapine significantly reduced PANSS score as compared to risperidone + clozapine compared to baseline and between 6 and 12 weeks. Risperidone +clozapine prolonged QTc interval (at 12 weeks) and elevated serum TG, VLDL, HDL significantly at 6 and 12 weeks. Conclusion Although addition of fluvoxamine and risperidone to clozapine are effective in management of chronic partially responsive schizophrenia on clozapine, fluvoxamine is more effective as well as safer compared to Risperidone when compared for 6 and 12 weeks in these patients.
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氟伏沙明与利培酮联合氯氮平治疗慢性部分反应性精神分裂症患者临床疗效、QTc间期及血脂的比较
目的研究比较氟伏沙明与利培酮对慢性部分反应性精神分裂症氯氮平治疗患者临床及实验室指标的增强作用。方法:前瞻性、随机、平行、开放标签研究,为期12周。在2007年1月至2008年6月期间,招募了20-60岁的精神分裂症患者,他们遵循DSM-IV诊断标准并接受氯氮平治疗,对治疗有部分反应。受试者随机分为两组:A组(n=28):在氯氮平治疗(25-200mg/天)的基础上加用氟伏沙明(25-50mg/天);B组(n=27):在氯氮平治疗的基础上加用利培酮(1-5mg/天)。6周、12周采用PANSS、BPRS评分及心电图、血脂检查评价药物疗效。结果:两组患者PANSS、BPRS评分均显著降低。与利培酮+氯氮平相比,氟伏沙明+氯氮平在6至12周期间显著降低了PANSS评分。利培酮+氯氮平延长QTc间期(12周),并在6周和12周显著升高血清TG、VLDL、HDL。结论氟伏沙明和利培酮联合氯氮平治疗慢性部分反应性精神分裂症是有效的,但在6周和12周的治疗中,氟伏沙明比利培酮更有效、更安全。
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