Citrome Leslie, Gommoll Carl P, Tang Xiongwen, Nunez Rene, Mathews Maju
aDepartment of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, New York bForest Research Institute, Jersey City, New Jersey, USA.
Int Clin Psychopharmacol. 2015 Mar;30(2):75-81. doi: 10.1097/YIC.0000000000000056.
The aim of this study was to evaluate the efficacy of vilazodone using different definitions of remission. Post-hoc analyses were carried out using data from an 8-week, multicenter, randomized, double-blind, placebo-controlled trial of vilazodone 40 mg/day in adults with major depressive disorder (NCT01473394). The primary efficacy endpoint was a mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score; additional measures included the Clinical Global Impressions-Severity (CGI-S) and Hamilton Rating Scale for Anxiety (HAMA) scores. In addition to treatment response (MADRS≥50% improvement), post-hoc analyses were carried out for remission of depressive symptoms [MADRS score≤10; MADRS≤5 (complete remission)], anxiety symptoms (HAMA≤7), and combined depression and anxiety symptoms (MADRS/HAMA≤10/≤7), as well as for overall symptom severity (CGI-S=1). Odds ratios (ORs) and numbers needed to treat (NNTs) were also calculated. Significant outcomes were obtained with vilazodone versus placebo for MADRS response (50.6 vs. 33.3%, OR=2.04, P<0.001, NNT=6), remission (34.0 vs. 21.8%, OR=1.82, P=0.003, NNT=9), and complete remission (18.2 vs. 8.3%, OR=2.42, P=0.002, NNT=11). More patients receiving vilazodone rather than placebo also met remission criteria for HAMA (48.8 vs. 35.2%, OR=1.82, P=0.002, NNT=8), MADRS/HAMA (32.1 vs. 20.4%, OR=1.83, P=0.004, NNT=9), and CGI-S (24.1 vs. 11.5%, OR=2.41, P<0.001, NNT=8). Treatment with vilazodone 40 mg/day may help adult patients with major depressive disorder achieve remission of depression and/or anxiety symptoms.
本研究的目的是使用不同的缓解定义来评估维拉唑酮的疗效。使用一项为期8周、多中心、随机、双盲、安慰剂对照试验的数据进行事后分析，该试验对患有重度抑郁症的成人患者使用每日40毫克维拉唑酮（NCT01473394）。主要疗效终点是蒙哥马利-Åsberg抑郁评定量表（MADRS）总分的平均变化；其他测量指标包括临床总体印象-严重程度（CGI-S）和汉密尔顿焦虑评定量表（HAMA）得分。除了治疗反应（MADRS改善≥50%）外，还对抑郁症状缓解[MADRS评分≤10；MADRS≤5（完全缓解）]、焦虑症状（HAMA≤7）、抑郁和焦虑症状合并（MADRS/HAMA≤10/≤7）以及总体症状严重程度（CGI-S=1）进行了事后分析。还计算了比值比（OR）和治疗所需人数（NNT）。与安慰剂相比，维拉唑酮在MADRS反应（50.6%对33.3%，OR=2.04，P<0.001，NNT=6）、缓解（34.0%对21.8%，OR=1.82，P=0.003，NNT=9）和完全缓解（18.2%对8.3%，OR=2.42，P=0.002，NNT=11）方面取得了显著结果。与安慰剂相比，更多接受维拉唑酮治疗的患者也达到了HAMA（48.8%对35.2%，OR=1.82，P=0.002，NNT=8）、MADRS/HAMA（32.1%对20.4%，OR=1.83，P=0.004，NNT=9）和CGI-S（24.1%对11.5%，OR=2.41，P<0.001，NNT=8）的缓解标准。每日40毫克维拉唑酮治疗可能有助于患有重度抑郁症的成年患者实现抑郁和/或焦虑症状的缓解。
