Psychiatry and Neurobehavioral Sciences, University of Virginia, 2955 Ivy Rd, Northridge Ste 210, Charlottesville, VA 22903
J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065.
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.
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).
At end point, compared to placebo, desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores (last-observation-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.
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.
ClinicalTrials.gov identifier: NCT01121484.
基于《精神障碍诊断与统计手册》第四版修订版（DSM-IV-TR）评估推荐剂量为 50mg/d 的度洛西汀在围绝经期和绝经后患有重性抑郁障碍（MDD）的女性中的 8 周疗效和安全性。
这是一项 4 期、多中心、平行分组、随机、双盲、安慰剂对照研究，于 2010 年 6 月 30 日至 2011 年 6 月 8 日进行。患者接受安慰剂或度洛西汀 50mg/d（1:1 比例；每组 217 例）。主要结局指标为第 8 周 17 项汉密尔顿抑郁量表（HDRS17）总分的变化。次要结局指标包括 Sheehan 残疾量表（SDS）、临床总体印象-改善量表（CGI-I）、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）和视觉模拟量表疼痛强度（VAS-PI）的变化。
在终点时，与安慰剂相比，度洛西汀与 HDRS17 总分的显著降低相关（末次观察结转分析；从基线的调整平均变化分别为-9.9 与-8.1，P =.004）和 CGI-I（P <.001）、MADRS（P =.002）、SDS（P =.038）和 VAS-PI（P <.001）的显著改善。SDS 和 VAS-PI 的改善在第 2 周时达到显著水平。度洛西汀通常安全且耐受良好。
度洛西汀 50mg/d 的短期治疗对围绝经期和绝经后女性 MDD 有效，疼痛和功能结局的改善早在第 2 周就明显。度洛西汀的安全性和耐受性与其他人群的数据一致。
ClinicalTrials.gov 标识符：NCT01121484。
