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Journal of Zhejiang University SCIENCE B
ISSN 1673-1581(Print), 1862-1783(Online), Monthly
2025 Vol.26 No.1 P.26-38
Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression
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.
Key words: Bipolar II depression; Lurasidone; Vortioxetine; Combination
1浙江大学医学院附属第一医院精神卫生科， 中国杭州市， 310003
2杭州市第一人民医院临床心理科， 中国杭州市， 310006
3浙江大学医学院附属第一医院临床药剂科， 中国杭州市， 310003
4富阳区第三人民医院， 中国杭州市， 311402
5南湖脑机交叉研究院， 中国杭州市， 311100
6全省精神障碍精准医疗重点实验室， 中国杭州市， 310003
7浙江大学医学院脑科学与脑医学学院， 教育部脑与脑机融合前沿科学中心， 中国杭州市， 310012
8浙江大学脑医学研究院， 中国杭州市， 310003
9浙江大学脑机智能国家重点实验室， 中国杭州市， 310003
10数理心理健康浙江省工程研究中心， 中国杭州市， 310003
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。
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DOI:
10.1631/jzus.B2400470
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On-line Access:
2025-01-14
Received:
2024-09-11
Revision Accepted:
2024-11-28
Crosschecked:
2024-12-17