{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T05:38:06Z","timestamp":1776749886385,"version":"3.51.2"},"reference-count":34,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003399","name":"Science and Technology Commission of Shanghai Municipality","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Psychiatry"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpsyt.2025.1521859","type":"journal-article","created":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T07:20:37Z","timestamp":1740554437000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and safety of electroacupuncture on treating mild to moderate first-episode depression: a study protocol for a randomized controlled trial"],"prefix":"10.3389","volume":"16","author":[{"given":"Jingyu","family":"Xia","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minghui","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuan","family":"Yin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zuqing","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haiyan","family":"Wei","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chuanyun","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanmei","family":"Hu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianhua","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shifen","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,2,26]]},"reference":[{"key":"B1","unstructured":"Depression"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02143-7","article-title":"Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic","volume":"398","year":"2021","journal-title":"Lancet Lond Engl"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(18)30511-X","article-title":"Prevalence of mental disorders in China: a cross-sectional epidemiological study","volume":"6","author":"Huang","year":"2019","journal-title":"Lancet Psychiatry"},{"key":"B4","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1001\/jama.2009.1943","article-title":"Antidepressant drug effects and depression severity: a patient-level meta-analysis","volume":"303","author":"Fournier","year":"2010","journal-title":"JAMA"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31948-2","article-title":"Depression","volume":"392","author":"Malhi","year":"2018","journal-title":"Lancet"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1002\/gps.1156","article-title":"A comparison of side effects of selective serotonin reuptake inhibitors and tricyclic antidepressants in older depressed patients: a meta-analysis","volume":"19","author":"Wilson","year":"2004","journal-title":"Int J Geriatr Psychiatry"},{"key":"B7","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1097\/00131746-200005000-00006","article-title":"The adverse effect profiles of the selective serotonin reuptake inhibitors: relationship to in vitroPharmacology","volume":"6","author":"Preskorn","year":"2000","journal-title":"J Psychiatr Pract"},{"key":"B8","doi-asserted-by":"publisher","first-page":"24","DOI":"10.1016\/j.jpsychires.2019.04.005","article-title":"Manual or\u00a0electroacupuncture as an add-on therapy to SSRIs for depression: A randomized\u00a0controlled trial","volume":"114","author":"Zhao","year":"2019","journal-title":"J Psychiatr Res"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2022.1012606","article-title":"Electroacupuncture as a rapid-onset and safer complementary therapy for depression: A systematic review and meta-analysis","volume":"13","author":"Zhang","year":"2023","journal-title":"Front Psychiatry"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1002\/da.22217","article-title":"Major depressive disorder in DSM-5: implications for clinical practice and research of changes from DSM-IV","volume":"31","author":"Uher","year":"2014","journal-title":"Depress Anxiety"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1612999","article-title":"Trial of electrical direct-current therapy versus escitalopram for depression","volume":"376","author":"Brunoni","year":"2017","journal-title":"N Engl J Med"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2003.10.016","article-title":"Assessment of blinding in clinical trials","volume":"25","author":"Bang","year":"2004","journal-title":"Control Clin Trials"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)10471-8","article-title":"Introducing a placebo needle into acupuncture research","volume":"352","author":"Streitberger","year":"1998","journal-title":"Lancet Lond Engl"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1016\/s0304-3959(99)00107-4","article-title":"Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis","volume":"83","author":"Kleinhenz","year":"1999","journal-title":"Pain"},{"key":"B15","doi-asserted-by":"crossref","DOI":"10.1007\/978-3-642-70486-4_14","article-title":"The Hamilton Rating Scale for Depression","volume-title":"Assessment of Depression","author":"Hamilton","year":"1986"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.3928\/0048-5713-20020901-06","article-title":"The PHQ-9: A new depression diagnostic and severity measure","volume":"32","author":"Kroenke","year":"2002","journal-title":"Psychiatr Ann"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.2001.016009606.x","article-title":"The PHQ-9: validity of a brief depression severity measure","volume":"16","author":"Kroenke","year":"2001","journal-title":"J Gen Intern Med"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.18.1737","article-title":"Validation and utility of a self-report version of PRIME-MD: the\u00a0PHQ primary care study | Psychiatry and behavioral health","volume":"282","author":"Spitzer","year":"1999","journal-title":"JAMA"},{"key":"B19","first-page":"1","volume-title":"SF-36 health survey. Manual and interpretation guide","author":"Ware","year":"1993"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2018.11.039","article-title":"Omega-3 polyunsaturated fatty acids and psychological intervention for workers with mild to moderate depression: A double-blind randomized controlled trial","volume":"245","author":"Tayama","year":"2019","journal-title":"J Affect Disord"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1080\/09638237.2017.1322181","article-title":"First episode indices associated with lifetime chronicity of depression among formerly depressed participants: an exploratory study","volume":"29","author":"Pereverseff","year":"2020","journal-title":"J Ment Health"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpr.2007.02.005","article-title":"Risk for recurrence in depression","volume":"27","author":"Burcusa","year":"2007","journal-title":"Clin Psychol Rev"},{"key":"B23","doi-asserted-by":"publisher","first-page":"1357","DOI":"10.1016\/S0140-6736(17)32802-7","article-title":"Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis","volume":"391","author":"Cipriani","year":"2018","journal-title":"Lancet Lond Engl"},{"key":"B24","doi-asserted-by":"publisher","first-page":"e8142","DOI":"10.1097\/MD.0000000000008142","article-title":"Efficacy of escitalopram monotherapy in the treatment of major depressive disorder","volume":"96","author":"Li","year":"2017","journal-title":"Med (Baltimore)"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1097\/YIC.0b013e32836458e2","article-title":"Comparison of escitalopram and paroxetine in the treatment of major depressive disorder","volume":"28","author":"Lin","year":"2013","journal-title":"Int Clin Psychopharmacol"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2015.01.048","article-title":"The benefit of combined\u00a0acupuncture and antidepressant medication for depression: A systematic review and meta-analysis","volume":"176","author":"Chan","year":"2015","journal-title":"J Affect Disord"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000022752","article-title":"The effect of acupuncture on depression and its correlation with metabolic alterations: A randomized controlled trial","volume":"99","author":"Li","year":"2020","journal-title":"Med (Baltimore)"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1186\/s13020-020-00421-y","article-title":"The mechanism of electroacupuncture for depression on basic research: a systematic review","volume":"16","author":"Han","year":"2021","journal-title":"Chin Med"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.20563","article-title":"Effect of electroacupuncture on insomnia in patients with depression: A randomized clinical trial","volume":"5","author":"Yin","year":"2022","journal-title":"JAMA Netw Open"},{"key":"B30","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1002\/ptr.5740","article-title":"Role of medicinal\u00a0plants for liver-qi regulation adjuvant therapy in post-stroke depression: A systematic review of literature","volume":"31","author":"Zeng","year":"2017","journal-title":"Phytother Res PTR"},{"key":"B31","unstructured":"Rules of Meridians and Acupoints Selection in Treatment of Parkinson\u2019s Disease Based on Data Mining Techniques\n          \n          2023"},{"key":"B32","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2019.00314","article-title":"Transcriptome analysis\u00a0on\u00a0maternal separation rats with depression-related manifestations ameliorated by electroacupuncture","volume":"13","author":"Zheng","year":"2019","journal-title":"Front Neurosci"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1089\/acu.2018.1285","article-title":"Study on the cerebral blood flow regulatory features of acupuncture at acupoints of the governor vessel","volume":"30","author":"Kim","year":"2018","journal-title":"Med Acupunct"},{"key":"B34","doi-asserted-by":"publisher","first-page":"497","DOI":"10.2147\/NSS.S253320","article-title":"Efficacy of electroacupuncture on treating depression-related insomnia: A randomized controlled trial","volume":"12","author":"Yin","year":"2020","journal-title":"Nat Sci Sleep"}],"container-title":["Frontiers in Psychiatry"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpsyt.2025.1521859\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T07:20:42Z","timestamp":1740554442000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpsyt.2025.1521859\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,26]]},"references-count":34,"alternative-id":["10.3389\/fpsyt.2025.1521859"],"URL":"https:\/\/doi.org\/10.3389\/fpsyt.2025.1521859","relation":{},"ISSN":["1664-0640"],"issn-type":[{"value":"1664-0640","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,26]]},"article-number":"1521859"}}