一项关于度洛西汀肠溶缓释片40 - 120毫克/天预防重度抑郁症患者复发的疗效和安全性的随机、双盲、安慰剂对照试验。 （注：原文中药物名称有误，正确的药物名称应该是度洛西汀肠溶缓释片，而不是左米那普明，这里按照正确的药物名称进行翻译）
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.
作者信息
Shiovitz Thomas, Greenberg William M, Chen Changzheng, Forero Giovanna, Gommoll Carl P
机构信息
Dr. Shiovitz with the California Neuroscience Research Medical Group Inc, Sherman Oaks, California; and Dr. Greenberg, Mr. Chen, Ms. Forero, and Mr. Gommoll are from Forest Research Institute, Jersey City, New Jersey.
出版信息
Innov Clin Neurosci. 2014 Jan;11(1-2):10-22.
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 (NCT01085812) 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.
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.
目的
重度抑郁症通常呈慢性，复发很常见。左旋米那普明缓释剂是一种强效且具有选择性的5-羟色胺及再摄取抑制剂，在美国被批准用于治疗成人重度抑郁症。本研究（NCT01085812）的目的是评估左旋米那普明缓释剂在预防重度抑郁症患者复发方面的疗效、安全性和耐受性。
设计
一项为期24周的III期随机、双盲、对照试验，比较40 - 120mg/天的左旋米那普明缓释剂与安慰剂对已接受12周开放标签左旋米那普明缓释剂治疗且有反应的重度抑郁症患者预防复发的效果。统计效能是在假设38%的安慰剂组患者和20%的左旋米那普明缓释剂组患者会复发的前提下计算得出的。
地点
美国和加拿大的36个门诊研究中心。
参与者
348名符合随机化标准并进入双盲治疗的患者中，3名在治疗前退出，112名被随机分配至安慰剂组，233名被随机分配至左旋米那普明缓释剂组。
主要结局
使用Cox比例风险回归模型分析复发时间，将治疗组和基线蒙哥马利-艾斯伯格抑郁评定量表评分作为解释变量。同时也评估了安全性。
结果
左旋米那普明缓释剂组的复发时间比安慰剂组长（风险比[95%置信区间]=0.68[0.40][1.17]），但治疗差异无统计学意义（P = 0.165）。两组中复发的患者比例相对较低（安慰剂组=20.5%，左旋米那普明缓释剂组=13.9%）。
结论
本研究未发现治疗组之间的差异，可能是由于安慰剂组的复发率低于预期。左旋米那普明缓释剂总体耐受性良好。
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