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Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

机译:阿戈美拉汀与舍曲林:观察性,开放标签和12周的疗效和耐受性的后续研究。

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Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline.
机译:目的在这项为期12周的开放标签随访研究中,我们旨在比较曲美拉汀与舍曲林的疗效和耐受性。方法成人精神病门诊的门诊患者出现新的抑郁症并被临床医生诊断为“重度抑郁发作”根据《精神疾病诊断和统计手册》第4版,并在研究中加入了处方的阿戈美拉汀(25 mg /天)或舍曲林(50 mg /天)。结果在第2周结束时,阿戈美拉汀组的蒙哥马利-阿斯伯格抑郁量表(MADRS)平均得分显着高于舍曲林组。但是,在3个月末时差异不明显。在第一周,阿戈美拉汀组的平均临床总体印象改善量表(CGI-I)得分低于舍曲林组。在研究结束时,平均CGI严重程度量表和CGI-I评分优于舍曲林组。舍曲林组的缓解率为46.7%,阿戈美拉汀组的缓解率为33.3%,两组的缓解率为76.7%。阿戈美拉汀组的任何患者均因不良反应而退学。阿戈美拉汀的副作用也较少。结论Agomelatine对抑郁症状起效快,对某些危重病例可能有益。考虑到MADRS评分,阿戈美拉汀似乎与舍曲林具有相似的疗效,但我们也指出需要进行长期研究,因为CGI评分在研究结束时对舍曲林组有利。与舍曲林相比,Agomelatine在停药和副作用数量方面均具有良好的耐受性。

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