Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression

Chunxiao DAI; Yaoyang FU; Xuanwei LI; Meihua LIN; Yinbo LI; Xiao LI; Keke HUANG; Chengcheng ZHOU; Jian XIE; Qingwei ZHAO; Shaohua HU

doi:10.1631/jzus.B2400470

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Research Articles | Updated：2025-01-10

Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression
Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression
沃替西汀辅助治疗双相抑郁发作的临床疗效和安全性
Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology) Vol. 26, Issue 1, Pages: 26-38(2025)
Affiliations：

1.Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou310003, China
2.Department of Clinical Psychology, Hangzhou First People's Hospital, Hangzhou310006, China
3.Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou310003, China
4.Fuyang Third People's Hospital, Hangzhou311402, China
5.Nanhu Brain-Computer Interface Institute, Hangzhou311100, China
6.The Zhejiang Key Laboratory of Precision Psychiatry, Hangzhou310003, China
7.School of Brain Science and Brain Medicine, and MOE Frontier Science Center for Brain Science and Brain-Machine Integration, Zhejiang University School of Medicine, Hangzhou310012, China
8.Brain Research Institute of Zhejiang University, Hangzhou310003, China
9.The State Key Lab of Brain-Machine Intelligence, Zhejiang University, Hangzhou310003, China
10.Zhejiang Engineering Center for Mathematical Mental Health, Hangzhou310003, China
Funds：
DOI：10.1631/jzus.B2400470
CLC：
CSTR：
Published： 15 January 2025 ，

Received： 11 September 2024 ，

Revised： 28 November 2024 ，
Accepted：

戴春晓,付瑶阳,励璇玮等.沃替西汀辅助治疗双相抑郁发作的临床疗效和安全性[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2025,26(01):26-38.

CHUNXIAO DAI, YAOYANG FU, XUANWEI LI, et al. Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression. [J]. Journal of zhejiang university-science b (biomedicine & biotechnology), 2025, 26(1): 26-38.
戴春晓,付瑶阳,励璇玮等.沃替西汀辅助治疗双相抑郁发作的临床疗效和安全性[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2025,26(01):26-38. DOI： 10.1631/jzus.B2400470.

CHUNXIAO DAI, YAOYANG FU, XUANWEI LI, et al. Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression. [J]. Journal of zhejiang university-science b (biomedicine & biotechnology), 2025, 26(1): 26-38. DOI： 10.1631/jzus.B2400470.

摘要

沃替西汀作为辅助药物治疗双相抑郁的有效性尚存争议，因此本研究旨在验证沃替西汀治疗双相抑郁的有效性和安全性。这项前瞻性、双中心、随机和为期12周的临床试验共纳入100名双相Ⅱ型抑郁患者。主要观察指标为Montgomery-Asberg抑郁评定量表（MADRS），临床有效判定为MADRS减分率≥50%。所有符合条件的患者初期均接受4周鲁拉西酮单药治疗，其中治疗有效的患者继续接受该单一疗法，而无效患者被随机分配到联合丙戊酸盐或联合沃替西汀组，疗程为8周。通过综合比较4~12周的MADRS结果，系统分析沃替西汀是否可以作为辅助药物治疗双相抑郁。结果显示：37例患者对鲁拉西酮单药治疗有效，而无效的60例患者随机分为丙戊酸组和沃替西汀组，疗程8周；经丙戊酸或沃替西汀联合治疗2周后，沃替西汀组的MADRS评分明显低于丙戊酸组；两组在8周和12周时的MADRS评分没有差异；副作用发生率在丙戊酸组和沃替西汀组之间没有显著差异。重要的是，沃替西汀组中有3名患者转为躁狂或轻躁狂。本研究显示，鲁拉西酮联合沃替西汀对早期双相II型抑郁有潜在的益处，但我们应密切监测疾病进展，避免转躁风险。

Abstract

Objective

Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial. This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression.

Methods

Patients with bipolar Ⅱ depression were enrolled in this prospective

two-center

randomized

12-week pilot trial. The main indicator for assessing treatment effectiveness was a Montgomery-Asberg Depression Rating Scale (MADRS) of ≥50%. All eligible patients initially received four weeks of lurasidone monotherapy. Patients who responded well continued to receive this kind of monotherapy. However

no-response patients were randomly assigned to either valproate or vortioxetine treatment for eight weeks. By comprehensively comparing the results of MADRS over a period of 4‍‒‍12 weeks

a systematic analysis was conducted to determine whether vortioxetine could be used as an adjuvant drug for treating bipolar depression.

Results

Thirty-seven patients responded to lurasidone monotherapy

and 60 patients were randomly assigned to the valproate or vortioxetine group for eight weeks. After two weeks of combined valproate or vortioxetine treatment

the MADRS score in the vortioxetine group was significantly lower than that in the valproate group. There was no difference in the MADRS scores between the two groups at 8 and 12 weeks. The incidence of side effects did not significantly differ between the valproate and vortioxetine groups. Importantly

three patients in the vortioxetine group appeared to switch to mania or hypomania.

Conclusions

This study suggested that lurasidone combination with vortioxetine might have potential benefits to bipolar II depression in the early stage

while disease progression should be monitored closely for the risk of switching to mania.

关键词

双相抑郁鲁拉西酮沃替西汀联合治疗

Keywords

Bipolar II depressionLurasidoneVortioxetineCombination

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