Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.
Curr Med Res Opin. 2021 Dec;37(12):2163-2173. doi: 10.1080/03007995.2021.1980869. Epub 2021 Oct 1.
The TREVIDA study aimed to evaluate vortioxetine for the treatment of major depressive disorder (MDD) in Taiwanese adults.
Patients with active depressive episode were recruited in this non-interventional, prospective, multi-site study conducted between June 2019 and August 2020 in Taiwan. Patient eligibility was independent of the physician's decision to prescribe vortioxetine for an MDD episode. Vortioxetine was initiated on the first visit. Depression severity, cognitive function, work productivity, functioning and safety were evaluated over 3 months.
Overall, 242 patients were analyzed. At baseline, 70.7% and 90.4% of patients had moderately severe-to-severe depression based on PHQ-9 (Patient Health Questionnaire-9) and TDQ (Taiwanese Depression Questionnaire), respectively. By Month 3, significant improvements from baseline in depression severity (mean [SD] changes in PHQ-9, TDQ and CGI-S [Clinical Global Impression-Severity]: -6.3 [7.3]; -13.2 [14.0]; -1.5 [1.3], respectively), cognitive function (mean [SD] change in PDQ-D: -8.0 [17.5]), functioning (mean [SD] change in SDS: -5.4 [7.6]), and presenteeism (38.9% from 56.3%), work productivity loss (40.9% from 58.7%) and activity impairment (43.2% from 61.0%) were observed ( < .001 for all). By month 3, patient-reported (PHQ-9) response and remission rates were 43.4% and 52.9%, respectively; physician-reported (CGI-S) response and remission rates were 29.0% and 31.6%, respectively. Vortioxetine was well-tolerated and no unexpected side effects were reported.
Vortioxetine reduced depression severity and improved cognitive function, work productivity, and functioning in Taiwanese patients with MDD in the real-world setting. Vortioxetine was well-tolerated in this Taiwanese population.
TREVIDA 研究旨在评估文拉法辛治疗台湾成年人重度抑郁症(MDD)。
本项非干预性、前瞻性、多中心研究于 2019 年 6 月至 2020 年 8 月在台湾进行,招募处于活跃抑郁发作期的患者。患者是否符合使用文拉法辛治疗 MDD 发作由医生决定,本研究不影响医生的决策。患者首次就诊时开始使用文拉法辛。研究在 3 个月内评估抑郁严重程度、认知功能、工作生产力、功能和安全性。
共分析了 242 例患者。基线时,70.7%和 90.4%的患者根据 PHQ-9(患者健康问卷-9)和 TDQ(台湾抑郁问卷)分别为中重度至重度抑郁。在第 3 个月时,抑郁严重程度(PHQ-9、TDQ 和 CGI-S[临床整体印象严重程度]的平均[标准差]变化:-6.3[7.3];-13.2[14.0];-1.5[1.3])、认知功能(PDQ-D 的平均[标准差]变化:-8.0[17.5])、功能(SDS 的平均[标准差]变化:-5.4[7.6])和出勤情况(56.3%降至 38.9%)、工作生产力损失(58.7%降至 40.9%)和活动障碍(61.0%降至 43.2%)均有显著改善(均<.001)。在第 3 个月时,患者报告的(PHQ-9)反应率和缓解率分别为 43.4%和 52.9%;医生报告的(CGI-S)反应率和缓解率分别为 29.0%和 31.6%。文拉法辛耐受性良好,未报告意外不良反应。
在现实环境中,文拉法辛降低了台湾 MDD 患者的抑郁严重程度,并改善了认知功能、工作生产力和功能。文拉法辛在台湾人群中具有良好的耐受性。