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Relapse prevention with levomilnacipran ER in adults with major depressive disorder: A multicenter, randomized, double‐blind, placebo‐controlled study

机译：随着主要抑郁症的成年人中左旋硝基吡普兰欧尔的复发预防：多中心，随机，双盲，安慰剂对照研究

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Background >Levomilnacipran extended release (ER) is a serotonin and norepinephrine reuptake inhibitor approved for major depressive disorder (MDD) in adults. This study was designed to evaluate relapse prevention with levomilnacipran ER in patients with MDD. </section> <section xml:id="da22872-sec-0020"> <title type="main">Methods > Patients (≥18 years) with MDD ( N ?=?644) received 20?weeks of open‐label treatment with levomilnacipran ER 40, 80, or 120?mg/d (8?weeks flexible dosing; 12?weeks fixed dosing). Patients with a Montgomery–?sberg Depression Rating Scale (MADRS) total score ≤12 from the end of week 8 to week 20 were randomized to 26 weeks of double‐blind treatment with levomilnacipran ER (same dosage; n ?=?165) or placebo ( n ?=?159). The primary efficacy endpoint was time to relapse, defined as insufficient therapeutic response (≥2‐point increase from randomization in Clinical Global Impression of Severity score, risk of suicide, need for hospitalization due to worsening of depression, or need for alternative antidepressant treatment as determined by the investigator) or an MADRS total score ≥18 at 2 consecutive visits. </section> <section xml:id="da22872-sec-0030"> <title type="main">Results > In the double‐blind intent‐to‐treat population, levomilnacipran ER‐treated patients had a significantly longer time to relapse compared with placebo (hazard ratio?=?0.56; 95% CI, 0.33–0.92; P? =?0.0212). Crude relapse rates were 14.5% (levomilnacipran ER) and 24.5% (placebo). Double‐blind treatment‐emergent adverse events (AEs) were reported for 58.8% and 56.0% of levomilnacipran ER and p </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译：</span><Abstract Type =“main”XML：lang =“en”> <部分XML：ID =“DA22872-SEC-0010”> <标题类型=“main”>背景</ title> > Levomilnacipran扩展释放（er ）是一名血清素和去甲肾上腺素再摄取抑制剂，用于成人的主要抑郁症（MDD）。本研究旨在评估MDD患者的Levomilnacipran ER复发预防。</ p> </ section> <section XML：ID =“DA22872-SEC-0020”> <标题类型=“main”>方法</标题> >患者（≥18岁），MDD（ n </ i>？=Δ444）接受20个，用Levomilnacipran ER 40,80或120？mg / d（8 ？周灵活给药; 12？周固定剂量）。蒙哥马利 - ？SBERG抑郁率刻度（MADRS）总分≤12从第8周结束到第20周的26周，用Levomilnacipran ER（相同剂量; n </ i >？=？165）或安慰剂（ n </ i>？=？159）。初级疗效终点是复发的时间，定义为治疗反应不足（≥2点从随机化因严重程度评分的临床全球印象中的随机性增加，因抑郁而导致的自杀风险，需要住院，或者需要替代抗抑郁药治疗由调查人员决定）或MADRS总得分≥18连续一次访问。 </ p> </ section> <section XML：ID =“da22872-ec-0030”> <标题类型=“main”>结果</ title> >在双盲意向治疗群体中，与安慰剂（危险比？= 0.56; 95％CI，0.33-0.92; = 0.0212）。原油复发率为14.5％（Levomilnacipran ER）和24.5％（安慰剂）。据报告双盲治疗 - 急促不良事件（AES）为58.8％和56.0％的Levomilnacipran和P. </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33" >著录项</h2> <ul> <li> <span class="lefttit">来源</span> <div style="width: 86%;vertical-align: text-top;display: inline-block;"> <a href='/journal-foreign-32884/'>《Depression and anxiety》</a> <b style="margin: 0 2px;">|</b><span>2019年第3期</span><b style="margin: 0 2px;">|</b><span>共10页</span> </div> </li> <li> <div class="author"> <span class="lefttit">作者</span> <p id="fAuthorthree" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Durgam Suresh&option=202" target="_blank" rel="nofollow">Durgam Suresh;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chen Changzheng&option=202" target="_blank" rel="nofollow">Chen Changzheng;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Migliore Raffaele&option=202" target="_blank" rel="nofollow">Migliore Raffaele;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Prakash Chandran&option=202" target="_blank" rel="nofollow">Prakash Chandran;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Thase Michael E.&option=202" target="_blank" rel="nofollow">Thase Michael E.;</a> </p> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zkzz" style="display: none;">展开▼</span> </div> </li> <li> <div style="display: flex;"> <span class="lefttit">作者单位</span> <div style="position: relative;margin-left: 3px;max-width: 639px;"> <div class="threelineshidden zhankaihshouqi" id="fOrgthree"> <p>AllerganMadison New Jersey;</p> <p>AllerganMadison New Jersey;</p> <p>AllerganMadison New Jersey;</p> <p>AllerganMadison New Jersey;</p> <p>University of Pennsylvania Health SystemPhiladelphia Pennsylvania;</p> </div> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zhdw" style="display: none;">展开▼</span> </div> </div> </li> <li > <span class="lefttit">收录信息</span> <span style="width: 86%;vertical-align: text-top;display: inline-block;"></span> </li> <li> <span class="lefttit">原文格式</span> <span>PDF</span> </li> <li> <span class="lefttit">正文语种</span> <span>eng</span> </li> <li> <span class="lefttit">中图分类</span> <span>R749.72; </span> </li> <li class="antistop"> <span class="lefttit">关键词</span> <p style="width: 86%;vertical-align: text-top;"> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=antidepressant&option=203" rel="nofollow">antidepressant;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=depression&option=203" rel="nofollow">depression;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=levomilnacipran extended release&option=203" rel="nofollow">levomilnacipran extended release;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=long‐term treatment&option=203" rel="nofollow">long‐term treatment;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=maintenance treatment&option=203" rel="nofollow">maintenance treatment;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=randomized withdrawal&option=203" rel="nofollow">randomized withdrawal;</a> </p> <div class="translation"> 机译：抗抑郁药;抑郁症;Levomilnacipran延长释放;长期治疗;维护治疗;随机撤离; </div> </li> </ul> </div> </div> <div class="literature cardcommon"> <div class="similarity "> <h3 class="all_title" id="enpatent66">相似文献</h3> <div class="similaritytab clearfix"> <ul> <li class="active" >外文文献</li> <li >中文文献</li> <li >专利</li> </ul> </div> <div class="similarity_details"> <ul > <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/journal-foreign-detail/0704025195538.html">Relapse prevention with levomilnacipran ER in adults with major depressive disorder: A multicenter, randomized, double‐blind, placebo‐controlled study</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Durgam Suresh&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Durgam Suresh,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chen Changzheng&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Chen Changzheng,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Migliore Raffaele&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Migliore Raffaele,</a> <a href="/journal-foreign-32884/" target="_blank" rel="nofollow" class="tuijian_authcolor">Depression and anxiety .</a> <span>2019</span><span>,第3期</span> </span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：随着主要抑郁症的成年人中左旋硝基吡普兰欧尔的复发预防：多中心，随机，双盲，安慰剂对照研究</span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/journal-foreign-detail/0704015293382.html">Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: A phase III, randomized, double-blind, fixed-dose, placebo-controlled study</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=BakishD.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">BakishD.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=BoseA.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">BoseA.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=GommollC.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">GommollC.,</a> <a href="/journal-foreign-35664/" target="_blank" rel="nofollow" class="tuijian_authcolor">Journal of psychiatry & neuroscience: JPN .</a> <span>2014</span><span>,第1期</span> </span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：患有严重抑郁症的左旋米那普仑ER 40 mg和80 mg：III期，随机，双盲，固定剂量，安慰剂对照研究</span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-journal-foreign_detail_thesis/0204117756128.html">A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40–120?mg/day) in patients with major depressive disorder</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Carl P. 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