Vortioxetine for depression in adults: A systematic review and dose–response meta‐analysis of randomized controlled trials

Author:

Yang Xin1,Fang Shuping1,Lyu Wenqi1ORCID,Hu Yongbo23,Xu Huifang4,Jiang Xiao5,Zhao Yurou14,Zhang Yuwei16,Li Jin1,Kuang Weihong1ORCID

Affiliation:

1. Department of Mental Health Center West China Hospital of Sichuan University Chengdu China

2. Department of Division of Neurology and Psychiatry West China Xiamen Hospital of Sichuan University Xiamen China

3. Department of Radiology, Huaxi MR Research Center (HMRRC) West China Hospital of Sichuan University Chengdu China

4. Department of Geriatric Psychiatry The Fourth People's Hospital of Chengdu Chengdu China

5. Department of Psychiatry Ziyang Psychosis Hospital Ziyang China

6. Department of Geriatric Chengdu Second People's Hospital Chengdu China

Abstract

AimMajor depressive disorder (MDD) is a prevalent psychiatric condition and vortioxetine offers promising antidepressant effects due to its unique pharmacological profile. However, the dose–response relationships of vortioxetine for MDD is not well established. We aimed to conduct dose–response meta‐analyses to fill this gap.MethodsWe systematically searched multiple electronic databases for randomized controlled trials of vortioxetine for MDD, with the last search conducted on 08 February, 2024. The dose–response relationship was evaluated using a one‐stage random‐effects dose–response meta‐analysis with restricted cubic spline model. The primary outcome was efficacy (mean change in depression scale score), with secondary outcomes including response, dropout for any reasons (acceptability), dropout for adverse events (tolerability), and any adverse events (safety).ResultsThe dose–response meta‐analysis comprised 16 studies, with 4,294 participants allocated to the vortioxetine group and 2,299 participants allocated to the placebo group. The estimated 50% effective dose was 4.37 mg/day, and the near‐maximal effective dose (95% effective dose) was 17.93 mg/day. Visual inspection of the dose‐efficacy curve suggests that a plateau possibly had not been reached yet at 20 mg/day. Acceptability, tolerability and safety decreased as the dose increased. Subgroup analysis indicated that no significant differences were observed in acceptability, tolerability and safety among the dosage groups.ConclusionsVortioxetine may potentially provide additional therapeutic benefits when exceeding the current licensed dosage without significantly impacting safety. Conducting clinical trials exceeding the current approved dosage appears necessary to fully comprehend its efficacy and risk.

Funder

National Key Research and Development Program of China

Publisher

Wiley

Reference54 articles.

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3. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015

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5. Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

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