Department of Neurology and Rehabilitation, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences, University of Chinese Academy of Sciences, Beijing, China.
BMJ Open. 2024 Sep 10;14(9):e091214. doi: 10.1136/bmjopen-2024-091214.
Major depressive disorder (MDD), the second leading cause of disability globally, is considered to be associated with a consequent deterioration in the quality of life and can lead to a major economic burden on medical service and suicide-related costs. Previous research has shown that acupuncture may be beneficial for treating MDD. However, there is a lack of rigorous evidence from previous studies comparing acupuncture with antidepressant medications. This study aims to assess the therapeutic potential of acupuncture in the management of depressive disorders.
A multicentre, randomised, participant-blind, sham-controlled, 2×2 factorial clinical trial, Acupuncture and Escitalopram for Treating Major Depression Clinical Study, aims to compare the efficacy of acupuncture versus escitalopram in treating depression. This study will be conducted at three hospitals in China, enrolling 260 patients with moderate-to-severe major depression, as defined by DSM-5 criteria and Hamilton Depression Rating Scale (HDRS-17) Scores above 17. Participants will be randomly assigned in equal proportions to one of four groups (acupuncture/escitalopram, sham acupuncture/escitalopram, acupuncture/placebo and sham acupuncture/placebo) and undergo 30 sessions across 10 weeks. The primary outcome is change in HDRS-17 Score and secondary outcomes include BDI, Clinical Global Impression, Generalised Anxiety Disorder-7 and Mini-Mental State Examination Scores, alongside potential biological markers.
Ethical approval for the study was granted by the Ethics Committees of the Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (2023-7th-HIRB-020), Shanghai Mental Health Centre (2022-86) and Shanghai Pudong New Area Hospital of Traditional Chinese Medicine (2023-003). Informed consent will be obtained from all participants. The study's findings are intended for publication in a scholarly journal.
NCT05901571.
重度抑郁症（MDD）是全球第二大致残原因，被认为与生活质量的相应恶化有关，并可能给医疗服务和与自杀相关的成本带来重大经济负担。先前的研究表明，针刺可能对治疗 MDD 有益。然而，以前的研究缺乏将针刺与抗抑郁药物进行比较的严格证据。本研究旨在评估针刺在管理抑郁障碍中的治疗潜力。
一项多中心、随机、参与者盲法、假对照、2×2 析因临床试验，即针刺和依地普仑治疗重度抑郁症临床研究，旨在比较针刺与依地普仑治疗抑郁症的疗效。这项研究将在中国的三家医院进行，招募 260 名符合 DSM-5 标准和汉密尔顿抑郁评定量表（HDRS-17）评分高于 17 分的中度至重度重度抑郁症患者。参与者将以相等的比例随机分配到四组之一（针刺/依地普仑、假针刺/依地普仑、针刺/安慰剂和假针刺/安慰剂），并在 10 周内进行 30 次治疗。主要结局是 HDRS-17 评分的变化，次要结局包括 BDI、临床总体印象、广泛性焦虑症-7 和简易精神状态检查评分，以及潜在的生物学标志物。
该研究已获得上海中医药大学第七人民医院伦理委员会（2023-7th-HIRB-020）、上海精神卫生中心（2022-86）和上海浦东新区中医医院（2023-003）的伦理批准。将从所有参与者那里获得知情同意。该研究的结果旨在发表在学术期刊上。
NCT05901571。
