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

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

Author: Chunxiao DAI ¹ ; Yaoyang FU ² ; Xuanwei LI ³ ; Meihua LIN ³ ; Yinbo LI ⁴ ; Xiao LI ³ ; Keke HUANG ³ ; Chengcheng ZHOU ⁴ ; Jian XIE ^{5
,

6} ; Qingwei ZHAO ^{6
,

7} ; Shaohua HU ^{6
,

8}
Author Information

1. Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
2. Department of Clinical Psychology, Hangzhou First People's Hospital, Hangzhou 310006, China.
3. Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
4. Fuyang Third People's Hospital, Hangzhou 311402, China.
5. Department of Clinical Psychology, Hangzhou First People's Hospital, Hangzhou 310006, China. srxjian@
6. com.
7. Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China. srxjian@
8. Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China. srxjian@
Publication Type:Multicenter Study
Keywords: Bipolar II depression; Combination; Lurasidone; Vortioxetine
MeSH: Humans; Bipolar Disorder/drug therapy*; Vortioxetine/therapeutic use*; Male; Female; Middle Aged; Adult; Valproic Acid/administration & dosage*; Lurasidone Hydrochloride/administration & dosage*; Prospective Studies; Treatment Outcome; Pilot Projects; Drug Therapy, Combination; Sulfides/therapeutic use*; Antidepressive Agents/therapeutic use*
From: Journal of Zhejiang University. Science. B 2025;26(1):26-38
CountryChina
Language:English
Abstract: OBJECTIVES: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.