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STUDY PROTOCOL article
Front. Psychiatry
Sec. Mood Disorders
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1521859
Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial
Provisionally accepted
Jingyu Xia 1 Minghui Jiang 2
Xuan Yin 1 Zuqing Wang 1 Feng Li 3
Haiyan Wei 4 Chuanyun Jin 4 Yanmei Hu 5
Jianhua Chen 6
Shifen Xu 1*- 1 Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China
- 2 Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai Municipality, China
- 3 Shanghai Research Center for Acupuncture and Meridians, Shanghai, Shanghai Municipality, China
- 4 Shanghai Pudong New District Nanhui Mental Health Center, Shanghai, China
- 5 Shanghai Xuhui Central Hospital, Shanghai, Shanghai Municipality, China
- 6 Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai, Shanghai Municipality, China
Only 30%-40% of patients with first-episode depression recover after taking antidepressants.Acupuncture is a clinically recognized treatment for depression, but its effect on first-episode depression remains unknown. This randomized controlled trial is designed to investigate the efficacy and safety of electroacupuncture (EA) compared with escitalopram (ESC) in treating patients with mild to moderate first-episode depression.This is a multi-site, single-blind, randomized controlled trial with two parallel arms. A total of 204 eligible patients will be randomly allocated to two groups: the EA group (receiving EA treatment with placebo drugs) and the ESC group (receiving escitalopram and sham acupuncture treatment).Treatment will last 12 weeks, with 3 sessions per week for the first 8 weeks, decreasing to 2 per week for the remaining 4 weeks. The primary outcome will be the score of the 17-item Hamilton Depression Rating Scale (HAMD-17), and the secondary outcomes will include depression recovery rate, depression remission rate, Patient Health Questionnaire-9 (PHQ-9), 36-Item Short Form Survey Instrument (SF-36), and the dose and frequency of ESC. The Treatment Emergent Symptom Scale (TESS) will be used to assess all adverse effects. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article.
Keywords: Electroacupuncture, Depression, protocol, randomized controlled trial, non-inferiority
Received: 03 Nov 2024; Accepted: 10 Feb 2025.
Copyright: © 2025 Xia, Jiang, Yin, Wang, Li, Wei, Jin, Hu, Chen and Xu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Shifen Xu, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China
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