Freeman Marlene P, Cheng Laura J, Moustafa Danna, Davies Abigail, Sosinsky Alexandra Z, Wang Betty, Petrillo Laura F, Hogan Charlotte, Cohen Lee S
Ammon-Pinizzotto Center for Women's, Mental Health, Massachusetts General Hospital, Boston, MA, USA. E-mail:
Ann Clin Psychiatry. 2017 Nov;29(4):249-257.
In a preliminary trial, we assessed the efficacy of vortioxetine for major depressive disorder (MDD) during the menopausal transition. Secondary outcomes included hot flashes (HFs), anxiety, and cognitive complaints.
Perimenopausal and early postmenopausal women with MDD (N = 27) received 8 weeks of open-label, flexible-dose treatment with vortioxetine. The Montgomery-Åsberg Depression Rating Scale (MADRS) was the primary outcome measure. Secondary measures included: HF frequency, the Greene Climacteric Scale (GCS), Menopause-Specific Quality of Life Questionnaire (MEN-QOL), Beck Anxiety Inventory (BAI), Cognitive and Physical Functioning Questionnaire (CPFQ), Digit Symbol Substitution Test (DSST), and Cogstate testing.
Of the 27 women, 24 (88.8%) were evaluated (≥1 follow-up), and 21 (77.8%) completed the study; 1 discontinued because of adverse effects. The mean MADRS score decreased significantly (P = .0001) from 31.3 (standard deviation [SD] = 5.5) at pretreatment to 8.1 (SD = 7.8) at posttreatment. The depression response rate (≥50% reduction in MADRS) and remission rate (final MADRS ≤10) were 75% and 70.8%, respectively. GCS, MEN-QOL, BAI, CPFQ, and DSST scores improved significantly (P = .0030, P = .0001, P = .0001, P = .0001, and P = .0133, respectively); Cogstate test scores did not. Frequency and severity of HFs improved significantly (P = .0291 and P = .0299, respectively).
These data support further study of vortioxetine for treating menopausal depression and associated symptoms.
在一项初步试验中，我们评估了伏硫西汀治疗绝经过渡期重度抑郁症（MDD）的疗效。次要结局包括潮热（HFs）、焦虑和认知主诉。
患有MDD的围绝经期和绝经后早期女性（N = 27）接受了为期8周的伏硫西汀开放标签、灵活剂量治疗。蒙哥马利-Åsberg抑郁评定量表（MADRS）是主要结局指标。次要指标包括：潮热频率、格林更年期量表（GCS）、更年期特异性生活质量问卷（MEN-QOL）、贝克焦虑量表（BAI）、认知与身体功能问卷（CPFQ）、数字符号替换测验（DSST）和Cogstate测试。
27名女性中，24名（88.8%）接受了评估（≥1次随访），21名（77.8%）完成了研究；1名因不良反应停药。MADRS平均得分从治疗前的31.3（标准差[SD]=5.5）显著降至治疗后的8.1（SD = 7.8）（P = .0001）。抑郁缓解率（MADRS降低≥50%）和缓解率（最终MADRS≤10）分别为75%和70.8%。GCS、MEN-QOL, BAI、CPFQ和DSST得分显著改善（分别为P = .0030、P = .0001、P = .0001、P = .0001和P = .0133）；Cogstate测试得分未改善。潮热的频率和严重程度显著改善（分别为P = .0291和P = .0299）。
这些数据支持进一步研究伏硫西汀治疗更年期抑郁症及相关症状。
