Jacobsen Paula L, Mahableshwarkar Atul R, Chen Yinzhong, Chrones Lambros, Clayton Anita H
Takeda Development Center Americas, Deerfield, IL, USA.
University of Virginia, Charlottesville, VA, USA.
J Sex Med. 2015 Oct;12(10):2036-48. doi: 10.1111/jsm.12980. Epub 2015 Aug 31.
Sexual dysfunction is common with serotonergic antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), and does not resolve in most patients. Vortioxetine, an antidepressant with a multimodal mechanism of action, has shown low rates of sexual dysfunction in previous major depressive disorder (MDD) trials.
This study compared the effects of vortioxetine and escitalopram on sexual functioning in adults with well-treated MDD experiencing treatment-emergent sexual dysfunction (TESD).
Participants treated with, and responding to, citalopram, paroxetine, or sertraline were randomized to switch to either vortioxetine (10/20 mg; n = 225) or escitalopram (10/20 mg; n = 222) for 8 weeks. Sexual function was assessed using the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14), and antidepressant efficacy was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions (CGI) scale, and Profile of Mood States brief form (POMS-brief). Safety and tolerability were also assessed.
The primary endpoint was change from baseline in the CSFQ-14 total score after 8 weeks of treatment. The MADRS, CGI, and POMS-brief were used to assess antidepressant efficacy. Safety was assessed via adverse events, vital signs, electrocardiograms, laboratory values, weight, and physical examination findings.
Vortioxetine showed significantly greater improvements in CSFQ-14 total score (8.8 ± 0.64, mean ± standard error) vs. escitalopram (6.6 ± 0.64; P = 0.013). Benefits vs. escitalopram were significant on four of five dimensions and all three phases of sexual functioning assessed by the CSFQ-14 (P < 0.05). Antidepressant efficacy continued in both groups, with similar, but slight, improvements in MADRS and CGI scores. Vortioxetine and escitalopram had similar clinical efficacy profiles in this study, with safety profiles similar to previous trials. Nausea (n = 9, 4.0%) was the most common treatment-emergent adverse event leading to discontinuation of vortioxetine.
Switching antidepressant therapy to vortioxetine may be beneficial for patients experiencing sexual dysfunction during antidepressant therapy with SSRIs.
性功能障碍在使用血清素能抗抑郁药时很常见，包括选择性5-羟色胺再摄取抑制剂（SSRIs）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs），且大多数患者的性功能障碍不会缓解。伏硫西汀是一种具有多模式作用机制的抗抑郁药，在先前的重度抑郁症（MDD）试验中显示性功能障碍发生率较低。
本研究比较了伏硫西汀和艾司西酞普兰对已接受充分治疗但出现治疗中突发性功能障碍（TESD）的成年MDD患者性功能的影响。
接受西酞普兰、帕罗西汀或舍曲林治疗且有反应的参与者被随机分为改用伏硫西汀（10/20毫克；n = 225）或艾司西酞普兰（10/20毫克；n = 222）治疗8周。使用性功能变化问卷简表（CSFQ-14）评估性功能，使用蒙哥马利-Åsberg抑郁评定量表（MADRS）、临床总体印象（CGI）量表和情绪状态简表（POMS-brief）评估抗抑郁疗效。同时评估安全性和耐受性。
主要终点是治疗8周后CSFQ-14总分相对于基线的变化。MADRS、CGI和POMS-brief用于评估抗抑郁疗效。通过不良事件、生命体征、心电图、实验室检查值、体重和体格检查结果评估安全性。
与艾司西酞普兰（6.6±0.64）相比，伏硫西汀在CSFQ-14总分上有显著更大的改善（8.8±0.64，平均值±标准误；P = 0.013）。在CSFQ-14评估的性功能的五个维度中的四个维度以及所有三个阶段，与艾司西酞普兰相比的益处均显著（P < 0.05）。两组的抗抑郁疗效均持续，MADRS和CGI评分有相似但轻微的改善。在本研究中，伏硫西汀和艾司西酞普兰具有相似的临床疗效特征，安全性特征与先前试验相似。恶心（n = 9，4.0%）是导致停用伏硫西汀的最常见治疗中突发不良事件。
将抗抑郁治疗换用伏硫西汀可能对在使用SSRIs进行抗抑郁治疗期间出现性功能障碍的患者有益。
