一项随机、安慰剂对照研究显示，度洛西汀治疗围绝经期和绝经后女性抑郁症的短期疗效和安全性。

Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.

机构信息

Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, Richmond, VA 23209-0710, USA.

出版信息

J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu.

DOI:10.4088/JCP.10m06018blu

PMID:20797382

Abstract

BACKGROUND

The risk for major depressive disorder (MDD) increases during the menopausal transition. Nonetheless, no large, placebo-controlled studies have prospectively assessed the efficacy of antidepressants in perimenopausal or postmenopausal women. This randomized, double-blind, placebo-controlled trial evaluated the short-term efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) in perimenopausal and postmenopausal women with DSM-IV-defined MDD.

METHOD

387 depressed perimenopausal and postmenopausal women aged 40 to 70 years were randomly assigned to placebo or desvenlafaxine (100 or 200 mg/d at the discretion of the investigator) in an 8-week, flexible-dose trial conducted from September 2006 to June 2008. The primary efficacy variable was change from baseline in 17-item Hamilton Depression Rating Scale (HDRS(17)) total score, analyzed using a mixed-effects model for repeated-measures analysis. Safety data were collected throughout the trial.

RESULTS

The reduction in adjusted HDRS17 total scores from baseline to week 8 (mean daily dose after titration, 162 to 176 mg/d) was significantly greater for desvenlafaxine (-12.64) compared with placebo (-8.33; P < .001). Statistical separation from placebo was observed at week 1 and was sustained through week 8. Both the perimenopausal and postmenopausal subgroups achieved significant reductions in HDRS(17) total scores with desvenlafaxine treatment (perimenopausal, P = .003; postmenopausal, P < .001). Response (58.6%) and remission (38.2%) rates were significantly higher for desvenlafaxine compared with placebo (31.6% [P < .001] and 22.4% [P = .008], respectively). In all, 19/256 (7.4%) desvenlafaxine-treated patients and 4/125 (3.2%) placebo-treated patients discontinued due to adverse events. Treatment-emergent adverse events were reported by 94/125 (75.2%) placebo-treated patients and 218/256 (85.2%) desvenlafaxine-treated patients.

CONCLUSIONS

Short-term treatment with desvenlafaxine was effective and generally well tolerated in perimenopausal and postmenopausal women with MDD.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00369343.

摘要

背景

在更年期过渡期间，发生重度抑郁症（MDD）的风险增加。尽管如此，仍没有大型、安慰剂对照研究前瞻性评估抗抑郁药在围绝经期或绝经后妇女中的疗效。这项随机、双盲、安慰剂对照试验评估了 DSM-IV 定义的 MDD 绝经前和绝经后妇女中去甲文拉法辛（作为去甲文拉法辛琥珀酸盐给予）的短期疗效和安全性。

方法

387 名年龄在 40 至 70 岁的抑郁围绝经期和绝经后妇女被随机分配至安慰剂或去甲文拉法辛组（研究人员自行决定给予 100 或 200mg/d），进行为期 8 周的灵活剂量试验，于 2006 年 9 月至 2008 年 6 月进行。主要疗效变量为 17 项汉密尔顿抑郁量表（HDRS（17））总分从基线的变化，采用重复测量混合效应模型进行分析。整个试验期间收集安全性数据。

结果

去甲文拉法辛（调整后平均日剂量为 162 至 176mg/d）治疗后从基线到第 8 周的 HDRS17 总分降低明显大于安慰剂组（-12.64 对-8.33；P<.001）。与安慰剂相比，去甲文拉法辛在第 1 周就观察到与安慰剂的统计学分离，并持续至第 8 周。去甲文拉法辛治疗绝经前和绝经后亚组的 HDRS（17）总分均显著降低（绝经前，P=.003；绝经后，P<.001）。去甲文拉法辛的反应（58.6%）和缓解（38.2%）率明显高于安慰剂（分别为 31.6%[P<.001]和 22.4%[P=.008]）。总共，256 名去甲文拉法辛治疗患者中有 19/256（7.4%）和 125 名安慰剂治疗患者中有 4/125（3.2%）因不良事件而停药。125 名安慰剂治疗患者中有 94/125（75.2%）和 256 名去甲文拉法辛治疗患者中有 218/256（85.2%）报告了治疗出现的不良事件。