Background: Depression is an increasingly important public health problem in China, but only a small minority of patients with this condition receive treatment. One of the reasons for low treatment rates is the relatively high cost of imported antidepressant medications.
Aim: Compare the efficacy and safety of the generic form of the selective serotonin re-uptake inhibitory (SSRI) antidepressant escitalopram to the proprietary form of escitalopram (Lexapro) in the treatment of major depression.
Methods: A multicenter double-blinded randomized controlled trial enrolled 260 patients with depression and randomly assigned them to receive eight weeks of treatment with either generic escitalopram (n=130) or Lexapro (n=130). Efficacy was assessed by the Hamilton rating scale for depression (HAMD-17). Safety was assessed by evaluating adverse events reported by patients, regularly recording vital signs, and conducting laboratory tests and electrocardiograms.
Results: There were 35 (27%) dropouts during the 8 weeks of treatment in the generic escitalopram group and 32 (25%) in the Lexapro group. In the intention-to-treat analysis (i.e., including all patients) the mean (s.d.) drop in the HAMD total score at the end of the 8th week of treatment was 13.9 (8.2) in the generic escitalopram group and 14.3 (8.1) in the Lexapro group (t=0.44, p=0.664). The proportions of patients responsive to treatment (i.e., >50% drop in total HAMD score) were 69% and 67% in the generic escitalopram group and Lexapro group, respectively (χ (2)=0.16, df=1, p=0.690; and the proportions that achieved remission (i.e., final HAMD <7) were 51% and 49% (χ (2)=0.06, df=1, p=0.804). The most frequently reported adverse events were dry mouth (12.3%), nausea (9.2 %) and dizziness (6.2%) in the generic escitalopram group and nausea (10.8%), fainting (7.7%) and drowsiness (6.9%) in the Lexapro group. During the first 35 days of treatment, one suicide and two suicide attempts occurred in the generic escitalopram group and one suicide occurred in the Lexapro group (Fisher exact test, p=0.314).
Conclusion: Generic escitalopram is as effective and safe as Lexapro in the initial treatment of patients with moderate to severe episodes of major depression who seek treatment in the outpatient departments of psychiatric hospitals in China. Careful monitoring of the risk of suicidal events is an essential component of the treatment of depressed patients.
Trial registration: NCT00866593 (clinical.trails.gov).
背景: 抑郁症已日益成为影响国人健康的公共卫生问题，但只有少部分抑郁症患者获得治疗。治疗率低的原因之一在于进口抗抑郁药治疗花费高昂。
目的: 比较选择性5-羟色胺再摄取抑制剂（Selective Serotonin Reuptake Inhibitors, SSRIs）艾司西酞普兰国产药草酸依地普仑片与专利药来士普治疗抑郁症的有效性和安全性。
方法: 采用随机双盲、阳性药平行对照、多中心临床研究，入组抑郁症病例260例，其中研究组（草酸依地普仑治疗组）和对照组（来士普组）各130例，治疗8周。主要疗效指标为17项汉密尔顿抑郁量表（Hamilton rating scale for depression, HAMD-17）评分。安全性评估包括不良事件、定期体检、实验室检查和心电图检查等。
结果: 为期8周的治疗中研究组有35名（27%）受试者脱落，对照组为32名（25%)。意向治疗分析（intention-to-treat analysis, ITT）发现治疗8周后，研究组的HAMD量表评分减分（标准差）为13.9（8.2）分，对照组为14.3（8.1）分（t=0.44, p=0.664）。研究组和对照组的有效率（HAMD减分率≥50%）分别为69%和67%（χ2=0.16, df=1, p=0.690）； 临床痊愈率（研究终点HAMD总分≤7分）分别为51%和49%（χ2=0.06, df=1, p=0.804）。研究组常见的不良反应为口干（12.3%）、恶心（9.2%）和头晕（6.2%），对照组为恶心（10.8%）、乏力（7.7%）和嗜睡（6.9%）。在研究的前35天中，治疗组出现1例自杀和2例自杀未遂，对照组出现1例自杀（Fisher精确检验，p=0.314)。
结论: 对在精神卫生中心门诊就诊的中、重度抑郁症患者，采用国产草酸依地普仑片与来士普初步治疗的疗效与安全性相当。治疗过程中需要严密关注自杀风险。
试验注册号: NCT00866593 (clinical.trails.gov).