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首页> 美国卫生研究院文献>Innovations in Clinical Neuroscience >A Randomized Double-blind Placebo-controlled Trial of the Efficacy and Safety of Levomilnacipran ER 40-120mg/day for Prevention of Relapse in Patients with Major Depressive Disorder
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A Randomized Double-blind Placebo-controlled Trial of the Efficacy and Safety of Levomilnacipran ER 40-120mg/day for Prevention of Relapse in Patients with Major Depressive Disorder

机译：Levomilnacipran ER 40-120mg / day的有效性和安全性的随机双盲安慰剂对照试验用于预防重度抑郁症患者的复发

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>Objective: Major depressive disorder is often chronic, with relapse and recurrence common. Levomilnacipran extended-release is a potent and selective serotonin and reuptake inhibitor approved in the United States for treatment of major depressive disorder in adults. The objective of this study () was to evaluate the efficacy, safety, and tolerability of levomilnacipran extended-release in the prevention of relapse in patients with major depressive disorder.>Design: A 24-week Phase III randomized, double-blind, controlled trial comparing levomilnacipran extended-release 40-120mg/day with placebo for relapse prevention in patients with major depressive disorder who had responded to 12-week, open-label treatment with levomilnacipran extended-release. Statistical power was calculated on the assumption that 38 percent of placebo and 20 percent of levomilnacipran extended-release patients would relapse.>Setting: Thirty-six outpatient study centers throughout the United States and Canada.>Participants: Of 348 patients who met randomization criteria and entered double-blind treatment, three discontinued prior to treatment, 112 were randomized to placebo, and 233 to levomilnacipran extended-release.>Measurements: Primary outcome: Time to relapse was analyzed using the Cox proportional hazard-regression model with treatment group and baseline Montgomery-Åsberg Depression Rating Scale score as explanatory variables. Safety was also evaluated.>Results: Time to relapse was longer for levomilnacipran extended-release versus placebo (hazard ratio [95% confidence interval] = 0.68 [0.40][1.17]), but the treatment difference was not statistically significant (P=0.165). A relatively low percentage of patients from either group relapsed (placebo=20.5%, levomilnacipran extended-release=13.9%).>Conclusion: This study did not detect between-treatment group differences, potentially due to lower than expected relapse rates in the placebo group. Levomilnacipran extended-release was generally well tolerated.
机译：>目的：严重的抑郁症通常是慢性的，复发和复发很常见。左旋米那普仑缓释是一种有效的，选择性的5-羟色胺和再摄取抑制剂，已在美国批准用于治疗成人的重度抑郁症。这项研究的目的是评估左旋米那普仑缓释在预防重度抑郁症患者复发中的功效，安全性和耐受性。>设计：为期24周的III期随机一项双盲，对照试验，比较了左旋米那普仑40-120mg /天与安慰剂对预防12周开放式左旋米那普仑缓释治疗有反应的重度抑郁症患者的复发预防。统计功效的计算是基于38％的安慰剂和20％的左旋米那普仑缓释患者会复发的假设。>设置：在美国和加拿大的36个门诊研究中心。>参与者：在348名符合随机标准并进入双盲治疗的患者中，三名在治疗前中断治疗，112例被随机分配给安慰剂，而233例左旋米那普仑缓释。>测量： ：使用Cox比例风险回归模型分析复发时间，以治疗组和基线蒙哥马利-奥斯伯格抑郁量表评分作为解释变量。 >结果：左旋米那普仑缓释与安慰剂相比，复发时间更长（危险比[95％置信区间] = 0.68 [0.40] [1.17]），但治疗差异为差异无统计学意义（P = 0.165）。两组中患者的复发率均相对较低（安慰剂= 20.5％，左旋米那普仑缓释= 13.9％）。>结论：该研究未检测到治疗之间的差异，可能是由于低于安慰剂组的预期复发率。左旋米那普仑缓释一般耐受良好。

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