Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial
IntroductionOnly 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 effica...
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Frontiers Media S.A.
2025-02-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1521859/full |
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| author | Jingyu Xia Minghui Jiang Xuan Yin Zuqing Wang Feng Li Haiyan Wei Chuanyun Jin Yanmei Hu Jianhua Chen Shifen Xu |
| author_facet | Jingyu Xia Minghui Jiang Xuan Yin Zuqing Wang Feng Li Haiyan Wei Chuanyun Jin Yanmei Hu Jianhua Chen Shifen Xu |
| author_sort | Jingyu Xia |
| collection | DOAJ |
| description | IntroductionOnly 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.Methods and analysisThis 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. |
| format | Article |
| id | doaj-art-67e3927e78f343e5b24cbdb367c6cdec |
| institution | OA Journals |
| issn | 1664-0640 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj-art-67e3927e78f343e5b24cbdb367c6cdec2025-08-20T02:03:36ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402025-02-011610.3389/fpsyt.2025.15218591521859Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trialJingyu Xia0Minghui Jiang1Xuan Yin2Zuqing Wang3Feng Li4Haiyan Wei5Chuanyun Jin6Yanmei Hu7Jianhua Chen8Shifen Xu9Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaInternational Education College, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, ChinaDepartment of Chinese Traditional Medicine, Shanghai Pudong New District Nanhui Mental Health Center, Shanghai, ChinaDepartment of Sleep Disorders, Shanghai Pudong New District Nanhui Mental Health Center, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Shanghai Xuhui District Central Hospital, Shanghai, ChinaShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaIntroductionOnly 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.Methods and analysisThis 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.https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1521859/fullelectroacupuncturedepressionprotocolrandomized controlled trialnon-inferiority |
| spellingShingle | Jingyu Xia Minghui Jiang Xuan Yin Zuqing Wang Feng Li Haiyan Wei Chuanyun Jin Yanmei Hu Jianhua Chen Shifen Xu Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial Frontiers in Psychiatry electroacupuncture depression protocol randomized controlled trial non-inferiority |
| title | Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial |
| title_full | Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial |
| title_fullStr | Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial |
| title_full_unstemmed | Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial |
| title_short | Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial |
| title_sort | efficacy and safety of electroacupuncture on treating mild to moderate first episode depression a study protocol for a randomized controlled trial |
| topic | electroacupuncture depression protocol randomized controlled trial non-inferiority |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1521859/full |
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