Department of Clinical Research, Torrent Research Centre, Village Bhat, Dist. Gandhinagar-382 428.
Indian J Psychiatry. 2004 Oct;46(4):333-41.
The present randomized, double blind, parallel group, controlled, multi-centric trial was designed to evaluate the efficacy and tolerability of escitalopram in comparison with citalopram and sertraline in the treatment of major depressive disorder. Outpatients (N=214) with an ongoing/newly diagnosed ICD-10 major depressive episode and a Hamilton Rating Scale for Depression (HAM-D) score of > 18 were randomly assigned to citalopram, 20-40 mg/day (74 patients), escitalopram, 10-20 mg/day (69 patients) and sertraline, 50-150 mg/day (71 patients), for a 4-week double-blind treatment period, with dosage adjustment (after 2 weeks of treatment) according to the response to treatment. Clinical response was evaluated by the 17 items HAM-D and the Clinical Global Impression (CGI) scales, which were recorded at baseline and at weekly intervals. Tolerability was evaluated by observed/spontaneously reported adverse changes in laboratory parameters (baseline and after 4 weeks). Response rate was defined as a decrease in HAM-D score by 50% from baseline and remission rate was defined as a HAM-D score of < 8. Response rate at the end of two week were 58% for escitalopram (10mg/day), 49% for citalopram (20mg/day) and 52% for sertraline (50-100mg/day). Response rate at the end of four week were 90% for escitalopram (10-20mg/day), 86% for citalopram (20-40mg/day) and 97% for sertraline (100-150mg/day). The Remission rates at the end of four weeks were 74% for escitalopram, 65% for citalopram and 77% for sertraline. Adverse experiences were reported by 45% of patients in escitalopram group, 58% patients in citalopram and 56% patients in the sertraline group. Additionally, there were lesser dropouts and lesser requirement for dose escalation in escitalopram than in citalopram and sertraline group. In conclusion Escitalopram, the Senantiomer of the citalopram is a safe and effective antidepressant in the Indian population. It has potentially superior efficacy than citalopram and a comparable efficacy to sertraline with fewer side effects than both citalopram and sertraline.
本随机、双盲、平行组、对照、多中心试验旨在评估艾司西酞普兰与西酞普兰和舍曲林相比在治疗重度抑郁症中的疗效和耐受性。入组患者（N=214）为正在进行/新诊断为 ICD-10 重度抑郁发作且汉密尔顿抑郁量表（HAM-D）评分>18 的门诊患者，他们被随机分配至西酞普兰组（20-40mg/天，74 例）、艾司西酞普兰组（10-20mg/天，69 例）和舍曲林组（50-150mg/天，71 例），进行为期 4 周的双盲治疗，根据治疗反应调整剂量（治疗 2 周后）。临床反应通过 17 项 HAM-D 和临床总体印象（CGI）量表进行评估，基线和每周记录一次。耐受性通过观察/自发报告的实验室参数（基线和 4 周后）不良变化进行评估。反应率定义为 HAM-D 评分从基线下降 50%，缓解率定义为 HAM-D 评分<8。治疗 2 周时的反应率分别为艾司西酞普兰（10mg/天）58%、西酞普兰（20mg/天）49%和舍曲林（50-100mg/天）52%。治疗 4 周时的反应率分别为艾司西酞普兰（10-20mg/天）90%、西酞普兰（20-40mg/天）86%和舍曲林（100-150mg/天）97%。治疗 4 周时的缓解率分别为艾司西酞普兰 74%、西酞普兰 65%和舍曲林 77%。艾司西酞普兰组有 45%的患者报告出现不良反应，西酞普兰组有 58%的患者报告出现不良反应，舍曲林组有 56%的患者报告出现不良反应。此外，艾司西酞普兰组的脱落率和剂量递增需求均低于西酞普兰组和舍曲林组。总之，艾司西酞普兰（西酞普兰的 S-对映体）是印度人群中一种安全有效的抗抑郁药。它的疗效可能优于西酞普兰，与舍曲林相当，且不良反应比西酞普兰和舍曲林少。
