University of Virginia Health System, PO Box 800623, Charlottesville, VA 22908-0623
J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.
To assess short-term efficacy and safety of desvenlafaxine 50 and 100 mg/d versus placebo for treating major depressive disorder (MDD). Assessment of sexual function was a secondary objective.
Outpatients (≥ 18 years) who met criteria for MDD from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision and had screening and baseline 17-item Hamilton Depression Rating Scale (HDRS17) total scores ≥ 20 were randomly assigned to placebo or desvenlafaxine 50 or 100 mg/d in an 8-week study conducted from October 2011 to August 2012. The primary efficacy end point was change from baseline in HDRS17 total score at week 8, analyzed using a mixed-effects model for repeated measures. Sexual function was assessed using the Arizona Sexual Experiences Scale (ASEX).
The safety population included 909 patients (intent-to-treat population, n = 886). Significantly greater improvement in adjusted mean HDRS17 total score from baseline to week 8 was observed for desvenlafaxine 50 mg (-11.28; P = .006) and desvenlafaxine 100 mg (-11.67; P < .001) compared with placebo (-9.71), with adjustment for multiplicity. In the ASEX total score analysis (n = 422), the treatment by gender interaction was not significant; thus, genders were combined for subsequent analyses. Comparisons for desvenlafaxine versus placebo for change from baseline in ASEX total and all item scores found P > .05, with no adjustment for multiplicity. Rates of sexual dysfunction based on ASEX were comparable among treatment groups.
These results support previous findings demonstrating antidepressant efficacy, safety, and tolerability of desvenlafaxine 50 and 100 mg/d versus placebo. Sexual function was comparable between desvenlafaxine and placebo.
ClinicalTrials.gov identifier: NCT01432457.
评估去甲文拉法辛 50mg 和 100mg/d 与安慰剂治疗重度抑郁症（MDD）的短期疗效和安全性。评估性功能是次要目标。
符合《精神障碍诊断与统计手册》第四版修订版（DSM-IV-TR）重度抑郁症标准的门诊患者（≥18 岁），且筛查和基线 17 项汉密尔顿抑郁量表（HDRS17）总分≥20 分，被随机分配至安慰剂或去甲文拉法辛 50mg 或 100mg/d 组，进行为期 8 周的研究，该研究于 2011 年 10 月至 2012 年 8 月进行。主要疗效终点为第 8 周时 HDRS17 总分相对于基线的变化，采用重复测量混合效应模型进行分析。性功能采用亚利桑那性经验量表（ASEX）评估。
安全性人群包括 909 例患者（意向治疗人群，n=886）。与安慰剂相比，去甲文拉法辛 50mg（-11.28；P=0.006）和去甲文拉法辛 100mg（-11.67；P<0.001）治疗后 HDRS17 总分相对于基线的调整平均改善更显著，调整多重性后差异有统计学意义。在 ASEX 总分分析中（n=422），治疗与性别交互作用无统计学意义；因此，对性别进行合并分析。与安慰剂相比，去甲文拉法辛治疗后 ASEX 总分及各项目评分的变化比较，P>.05，未进行多重性调整。基于 ASEX 的性功能障碍发生率在各治疗组之间相似。
这些结果支持之前的研究结果，表明去甲文拉法辛 50mg 和 100mg/d 与安慰剂相比具有抗抑郁疗效、安全性和耐受性。去甲文拉法辛与安慰剂的性功能相当。
ClinicalTrials.gov 标识符：NCT01432457。
