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首页> 外文期刊>The journal of clinical psychiatry >Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder: A randomized controlled trial
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Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder: A randomized controlled trial

机译：地塞拉法辛50 mg / d预防主要抑郁症复发的功效和安全性：一项随机对照试验

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Objective: To evaluate the long-term (11-month) efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) at the recommended 50-mg/d dose in preventing relapse in patients with major depressive disorder (MDD). Method: Adult outpatients (age ?? 18 years) with MDD (DSM-IV criteria) and a 17-item Hamilton Depression Rating Scale (HDRS17) total score ?? 20 at screening and baseline were enrolled in a multicenter, doubleblind, placebo-controlled, randomized withdrawal trial conducted between June 2009 and March 2011. Patients who responded to 8-week open-label treatment with desvenlafaxine 50 mg/d with continuing stable response through week 20 were randomly assigned to receive placebo or desvenlafaxine 50 mg/d in a 6-month, doubleblind, randomized withdrawal period. The primary efficacy endpoint was time to relapse following randomization to double-blind treatment, which was compared between groups using the log-rank test. Relapse was defined as HDRS17 total score ?? 16, discontinuation for unsatisfactory response, hospitalization for depression, suicide attempt, or suicide. Safety and tolerability data were collected throughout the trial. Results: A total of 874 patients were enrolled; 548 patients were randomly assigned to receive placebo (n = 276) or desvenlafaxine 50 mg/d (n = 272) in the double-blind withdrawal period. Time to relapse was significantly shorter for placebo versus desvenlafaxine (P .001). At the end of the 6-month double-blind treatment, the estimated probability of relapse was 30.2% for placebo versus 14.3% for desvenlafaxine 50 mg/d. Safety and tolerability results were generally consistent with those in short-term studies of desvenlafaxine 50 mg/d. Conclusions: Desvenlafaxine at the recommended dose of 50 mg/d was effective in relapse prevention of depression during a 6-month period in patients who demonstrated stable response after 20 weeks of open-label desvenlafaxine treatment. ?
机译：目的：评估以建议的50 mg / d剂量服用desvenlafaxine（琥珀酸desvenlafaxine）的长期（11个月）有效性和安全性，以预防重度抑郁症（MDD）患者的复发。方法：成年门诊患者（≥18岁），具有MDD（DSM-IV标准）和17个项的汉密尔顿抑郁量表（HDRS17）总分？于2009年6月至2011年3月进行的一项多中心，双盲，安慰剂对照，随机退出试验的筛查和基线试验中，有20例入选。对使用8毫克地文拉法辛50 mg / d的8周开放标签治疗有效且持续稳定的患者第20周随机分配，在6个月的双盲随机停药期内接受安慰剂或去甲文拉法辛50 mg / d。主要功效终点是随机分配至双盲治疗后的复发时间，使用对数秩检验对各组之间进行比较。复发定义为HDRS17总分16，因反应不佳而停药，因抑郁，自杀未遂或自杀而住院。在整个试验过程中收集了安全性和耐受性数据。结果：共纳入874例患者。 548名患者在双盲停药期被随机分配接受安慰剂（n = 276）或去甲文拉法辛50 mg / d（n = 272）。与去甲文拉法辛相比，安慰剂的复发时间明显缩短（P <.001）。在为期6个月的双盲治疗结束时，安慰剂的估计复发概率为30.2％，而去甲文拉法辛50 mg / d的复发概率为14.3％。安全性和耐受性结果与去甲文拉法辛50 mg / d的短期研究大致一致。结论：在公开标签的去甲文拉法辛治疗20周后表现出稳定反应的患者中，建议剂量50 mg / d的去甲文拉法辛可有效预防6个月的抑郁症复发。 ？

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