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首页> 外文期刊>The journal of clinical psychiatry >Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder
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Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder

机译：Desvenlafaxine 50 mg / d的疗效和安全性在随机，安慰剂对照研究中具有重大抑郁症的妇女期和绝经后妇女的研究

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Objective: Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Method: This phase 4, multicenter, parallel-group, randomized, double-blind, placebo-controlled study was conducted from June 30, 2010, to June 8, 2011. Patients received placebo or desvenlafaxine 50 mg/d (1:1 ratio; n = 217 in each group). The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale (HDRS17) total score. Secondary outcome measures included change in the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Improvement scale (CGI-I), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Visual Analog Scale-Pain Intensity (VAS-PI). Results: At end point, compared to placebo, desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores (lastobservation-carried-forward analysis; adjusted mean change from baseline -9.9 vs -8.1, respectively; P = .004) and significant improvements on the CGI-I (P .001), MADRS (P = .002), SDS (P = .038), and VAS-PI (P .001). Improvements on the SDS and VAS-PI reached significance by week 2. Desvenlafaxine was generally safe and well tolerated. Conclusions: Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women, with significant benefits on pain and functional outcomes evident as early as week 2. The safety and tolerability of desvenlafaxine were consistent with data in other populations.
机译：目的：基于精神障碍，第四版，文本修订的诊断和统计手册，评价患有主要抑郁症（MDD）的预推荐剂量的80mg / d的80mg / d的疗效和安全性。方法：本阶段4，多中心，并行组，随机，双盲，安慰剂对照研究于2010年6月30日至6月8日从2011年6月8日开始。患者接受安慰剂或拒绝（1：1比例）50mg / d（1：1比例;每组n = 217）。主要成果措施是第8周的变化，在17项汉密尔顿抑郁率秤（HDRS17）总得分。次要结果措施包括Sheehan残疾规模（SDS），临床全球印象改变（CGI-I），蒙哥马利 - Asberg抑郁率（Madrs）以及视觉模拟疼痛强度（VAS-PI） ）。结果：在终点中，与安慰剂相比，Desvenlafaxine与HDRS17总分比的显着降低有关（Lastobservation-over-前进分析;从基线调整的平均变化分别; P = .004）和重要的CGI-I（P = .001），MADRS（P = .002），SDS（P = .038）和VAS-PI（P＆ .001）上的改进。 SDS和VAS-PI的改善达到了第2周的意义。DESvenlafaxine通常是安全和耐受性的。结论：缺乏缺口50mg / d的短期治疗对于治疗围囊肿和绝经后妇女的MDD有效，随着第2周尽早就明显明显明显的痛苦和功能性效果。DESvenlafaxine的安全性和耐受性与数据一致在其他人口。

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  • 来源
    《The journal of clinical psychiatry》 |2013年第10期|共8页
  • 作者

    ClaytonA.H.; KornsteinS.G.; DunlopB.W.; FochtK.; MusgnungJ.; RameyT.; BaoW.; NinanP.T.;

  • 作者单位

    Psychiatry and Neurobehavioral Sciences University of Virginia 2955 Ivy Rd Northridge;

    Institute for Women's Health Virginia Commonwealth University Richmond United States;

    Emory University School of Medicine Atlanta GA United States;

    Pfizer Inc. Collegeville PA United States;

    Pfizer Inc. Collegeville PA United States;

    Pfizer Inc. Groton CT United States;

    Pfizer Inc. Collegeville PA United States;

    Pfizer Inc. Collegeville PA United States;

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  • 正文语种 eng
  • 中图分类 精神病学;
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