度洛西汀与酞和安慰剂治疗重度抑郁症患者:抗抑郁发作行动,non-inferiority研究。

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Nierenberg AA, Greist JH Mallinckrodt CH,普拉卡什,Sambunaris, Tollefson GD, Wohlreich毫米

度洛西汀与酞和安慰剂治疗重度抑郁症患者:抗抑郁发作行动,non-inferiority研究。

咕咕叫地中海Res当今。2007年2月,23 (2):401 - 16。

PubMed ID

17288694 (在PubMed

]

文摘

目的:non-inferiority研究的目的是为了测试是否一个新的治疗至少尽可能多的功效一个既定治疗。这non-inferiority研究的目的是比较发病的速度度洛西汀的抗抑郁疗效(双5 -羟色胺和去甲肾上腺素再摄取抑制剂)和酞(选择性5 -羟色胺再摄取抑制剂)。研究设计和方法:这是一个随机、双盲、安慰剂和活跃comparator-controlled研究,患者(> = 18年)会议为重度抑郁症诊断标准(MDD)接受度洛西丁60毫克每天一次(QD;N = 273)、酞10毫克QD (N = 274),或安慰剂(N = 137) 8周。发病的主要目标是比较抗抑郁疗效,通过测试的假设duloxetine-treated病人发病达到标准的百分比在星期2不次于酞组。主要结果测量:发作疗效被定义为从基线降低20%测量表汉密尔顿抑郁量表(HAMD)(17)麦尔内部氧化物,保持或超过所有后续访问。结果:发病概率的标准在星期2度洛西丁escitalopram-treated患者分别为42.6%和35.2%,分别(治疗差异= 7.4%;95%置信区间,-1.3%到16.2%;p = 0.097)。这两种药物与安慰剂相比有了明显的改善(p <或= 0.05)的主要疗效指标(麦尔子量表)在周1和端点(第八周)。没有发现差异度洛西汀、酞,缓解率和安慰剂在8周或响应。 Adverse events that occurred significantly more frequently among duloxetine-treated patients when compared with those receiving escitalopram were nausea, dry mouth, vomiting, yawning, and irritability. The rate of discontinuation due to adverse events did not differ significantly between treatment groups. LIMITATIONS: Given the difficulties in constructing appropriate dose comparisons, the results of this study should be interpreted specific to the doses tested and not extrapolated to the drug as a whole. This study employed a fixed-dose design; flexible-dose designs are more likely to find a difference between antidepressants and placebo. CONCLUSION: In this study, both duloxetine and escitalopram showed significantly greater improvement on the primary efficacy measure than placebo over the 8-week acute treatment period, while no differences were observed between drugs or between drugs and placebo on response and remission rates at 8 weeks. Escitalopram at a starting dose of 10 mg QD was better tolerated than duloxetine at a starting dose of 60 mg QD. This study met its pre-defined primary objective of assessing if duloxetine was non-inferior to escitalopram in antidepressant onset efficacy, and the results show that duloxetine is at least as fast as (non-inferior to) escitalopram.

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药物

酞