Lundbeck Hellas, 109 Kifisias Avenue & Sina, 15124, Maroussi, Athens, Greece.
4th Psychiatric Department, Psychiatric Hospital of Attica, Athens, Greece.
BMC Psychiatry. 2022 Aug 12;22(1):548. doi: 10.1186/s12888-022-04109-5.
Functional recovery is an important treatment goal in major depressive disorder (MDD). This study assessed the real-world effectiveness of vortioxetine in patients with MDD, with particular focus on functioning; dose-response was also assessed.
This was a non-interventional, prospective, multicenter study conducted in Greece. Adult outpatients with MDD (n = 336) initiating vortioxetine (5-20 mg/day flexible dosing) as treatment for a current major depressive episode were followed for 3 months. Analyses were stratified according to vortioxetine dosage at 3 months: 5-10 mg/day versus 15-20 mg/day. Functioning was assessed using the Sheehan Disability Scale (SDS).
Mean ± standard error SDS total score decreased (improved) from 18.7 ± 0.3 at baseline to 12.9 ± 0.3 after 1 month of vortioxetine treatment and 7.8 ± 0.4 after 3 months (p < 0.001 vs. baseline for all comparisons). Functional recovery (SDS score ≤ 6) was achieved in 14.6% of patients after 1 month of treatment and 48.4% of patients after 3 months. Improvement from baseline in SDS total and domain scores at 3 months was more pronounced in patients receiving vortioxetine 15-20 mg/day than in those receiving vortioxetine 5-10 mg/day. The mean ± standard error change in SDS total score from baseline was 9.2 ± 0.8 in the 5-10 mg/day group and 12.1 ± 0.4 in the 15-20 mg/day group (p < 0.001). Limitations of this study include its non-interventional study design and lack of a control group or active comparator.
Statistically significant and clinically relevant improvements in functioning were seen in patients with MDD treated with vortioxetine in a real-world setting. Higher doses of vortioxetine were associated with significantly greater improvements in functioning.
功能恢复是重度抑郁症（MDD）的重要治疗目标。本研究评估了在现实世界中使用文拉法辛治疗 MDD 患者的疗效，特别关注其功能；还评估了剂量反应。
这是一项在希腊进行的非干预性、前瞻性、多中心研究。正在接受文拉法辛（5-20mg/天灵活剂量）治疗当前重度抑郁发作的成年门诊患者（n=336）参与了本研究，并随访 3 个月。根据 3 个月时文拉法辛的剂量对分析进行分层：5-10mg/天与 15-20mg/天。使用 Sheehan 残疾量表（SDS）评估功能。
SDS 总分（平均值±标准误差）从基线时的 18.7±0.3 分降低（改善）至文拉法辛治疗 1 个月时的 12.9±0.3 分和 3 个月时的 7.8±0.4 分（与基线相比，所有比较均<0.001）。治疗 1 个月后，14.6%的患者达到 SDS 评分≤6，3 个月后，48.4%的患者达到 SDS 评分≤6。与接受文拉法辛 5-10mg/天治疗的患者相比，接受文拉法辛 15-20mg/天治疗的患者在 3 个月时 SDS 总分和各领域评分的改善更为明显。从基线到 3 个月时，SDS 总分的平均（±标准误差）变化在 5-10mg/天组为 9.2±0.8，在 15-20mg/天组为 12.1±0.4（p<0.001）。本研究的局限性包括其非干预性研究设计和缺乏对照组或活性对照。
在现实环境中，使用文拉法辛治疗 MDD 患者的功能有显著且有临床意义的改善。较高剂量的文拉法辛与功能的显著改善相关。
