H. Lundbeck A/S, Valby, Denmark.
Lundbeck Singapore Pte. Ltd, Singapore, Singapore.
Curr Med Res Opin. 2024 Sep;40(9):1637-1645. doi: 10.1080/03007995.2024.2382773. Epub 2024 Aug 7.
Vortioxetine has demonstrated safety and efficacy in improving symptoms of major depressive disorder (MDD), including overall functioning in real-world settings. This is the first study in a real-life clinical setting in India to evaluate effectiveness and safety of vortioxetine in patients with MDD.
This interventional, open-label study consisted of a 12-week treatment period with flexible doses of vortioxetine (5-20 mg/day) in adult patients (aged 18-65 years) with a confirmed MDD diagnosis. Effectiveness outcomes included change from baseline to week 12 in Patient Health Questionnaire-9 (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scores, along with CGI-Improvement (CGI-I) scores at week 12, using a mixed model for repeated measures. Adverse events (AEs) were recorded for safety outcome assessments.
Of 395 patients who received vortioxetine, 42.3% were women mean age 38.9 years; 322 patients completed the study. Significant improvement in depressive symptoms was observed in change from baseline to week 12 least squares (LS) mean (SE) PHQ-9 total score (-9.36 [0.276]; <.0001) and CGI-S score (-2.14 [0.065]; <.0001). LS mean (SE) CGI-I score showed significant improvement at week 12 (1.93 [0.067]; <.0001). Subgroup analysis across age, sex, disease severity, and body mass index showed significant improvements in depression symptoms and severity. A total of 35.4% ( = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, = 26 each).
Safety and effectiveness of vortioxetine in improving symptoms of MDD over a 12-week period was demonstrated in a real-life clinical setting in India.
Open-label, flexible-dose study of vortioxetine in patients with major depressive disorder in India; Clinical Trials.gov ID: NCT04288895; https://www.clinicaltrials.gov/study/NCT04288895.
文拉法辛已被证明能安全有效地改善重度抑郁症（MDD）的症状，包括在现实环境中整体功能的改善。这是印度首个在真实临床环境中评估文拉法辛治疗 MDD 患者的有效性和安全性的研究。
这是一项开放性、干预性研究，共 12 周的治疗期，成年患者（18-65 岁）接受文拉法辛（5-20mg/天）的灵活剂量治疗。有效性结局包括从基线到第 12 周时患者健康问卷-9（PHQ-9）和临床总体印象-严重程度（CGI-S）评分的变化，以及第 12 周时 CGI-I 评分的改善，采用重复测量混合模型进行分析。记录不良事件（AE）以评估安全性结局。
在接受文拉法辛治疗的 395 例患者中，42.3%为女性，平均年龄为 38.9 岁；322 例患者完成了研究。从基线到第 12 周时，PHQ-9 总分（-9.36 [0.276]；<.0001）和 CGI-S 评分（-2.14 [0.065]；<.0001）的最小二乘（LS）均值（SE）均显示出抑郁症状显著改善。第 12 周时，LS 均值（SE）CGI-I 评分显示出显著改善（1.93 [0.067]；<.0001）。在年龄、性别、疾病严重程度和体重指数的亚组分析中，抑郁症状和严重程度均显示出显著改善。共有 35.4%（140 例）的患者发生治疗引起的不良事件（多为轻中度）；最常见的不良事件为恶心和瘙痒（各 6.6%，分别为 26 例）。
在印度的真实临床环境中，文拉法辛治疗 12 周可改善 MDD 患者的症状，安全性和有效性得到证实。
印度文拉法辛治疗重度抑郁症患者的开放性、灵活剂量研究；临床试验.gov 标识符：NCT04288895；https://www.clinicaltrials.gov/study/NCT04288895。
