Multimodal MRI Study of Acupuncture's Rapid Antidepressant Mechanisms and Response Prediction in Depression
2026年5月22日 更新者：Fan Chunling,MD、Second Affiliated Hospital of Tsinghua University
A Multimodal MRI-Based Study on the Rapid Antidepressant Mechanisms of Acupuncture and Individualized Treatment Response Prediction in Depression
This study aims to investigate the rapid antidepressant effects of acupuncture and to explore the underlying brain mechanisms using multimodal MRI techniques. In addition, the study will evaluate whether individual treatment responses can be predicted based on neuroimaging and clinical data.
Participants diagnosed with mild to moderate depression will be enrolled and will receive acupuncture treatment. Depression-related clinical assessment scales and brain imaging data will be collected before and after treatment.
The results of this study may help to better understand the mechanisms of acupuncture in rapid antidepressant treatment and support the development of personalized treatment strategies.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Chunling Fan, M.D.
- 电话号码：+86 10 89926000
- 邮箱：fanjingzi1@126.com
研究联系人备份
- 姓名：YU MA, M.D.
- 电话号码：+86 10 89926000
- 邮箱：mayu@tsinghua.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Aged 18 to 59 years, and right-handed;
- Patients who have received systematic antidepressant treatment (including antidepressant medications, sedative-hypnotics, electroconvulsive therapy, or transcranial magnetic stimulation) within the 4 weeks prior to enrollment;
- Having a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) greater than 7 and less than or equal to 24;
- Voluntary participation in the study, with written informed consent provided by the patient themselves or their legally authorized guardian.
Exclusion Criteria:
- Diagnosis of other major psychiatric disorders or presence of psychotic symptoms.
- History of other severe somatic diseases (e.g., cardiovascular/cerebrovascular diseases, autoimmune diseases), or current/past neurological or organic brain diseases.
- Current or past history of alcohol dependence or abuse of other psychoactive substances.
- Women who are lactating, pregnant, or menstruating.
- Patients who have participated in other clinical drug trials within the past 3 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Acupuncture group
Participants in the acupuncture group will receive real acupuncture treatment.
Acupoints will be selected according to the Chinese national standard "Nomenclature and Location of Meridian Points" (GB/T 12346-2006), including Baihui (GV20), Sishencong (EX-HN1), Shenting (GV24), Touwei (ST8), Fengchi (GB20), Anmian (EX-HN22), Neiguan (PC6), Shenmen (HT7), and Sanyinjiao (SP6).
Electrical stimulation will be applied using sparse-dense waves at frequencies of 2 Hz and 100 Hz, with an intensity ranging from 0.1 to 1 mA.
Treatment will be performed by licensed acupuncturists following a standardized operation manual.
Each acupuncture session lasts 30 minutes, and participants will receive one session of acupuncture treatment.
Participants will remain blinded to group allocation.
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Participants will receive standardized acupuncture treatment for mild to moderate depression according to the study protocol.
Acupuncture will be administered by qualified practitioners at predefined acupoints during the treatment period.
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假比较器：Sham Acupuncture Group
Participants in the sham acupuncture group will receive sham acupuncture using non-insertive placebo needles.
The same acupoints and treatment protocol will be applied as in the acupuncture group (sham acupuncture session lasting 30 minutes, single session).
The procedure mimics real acupuncture without skin penetration or active stimulation, and appears visually indistinguishable from real acupuncture.
The electroacupuncture device will not deliver electrical output.
Participants will remain blinded to group allocation.
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Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Montgomery-Åsberg Depression Rating Scale Score
大体时间：Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Change in short-term depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item scale with a total score ranging from 0 to 60. Higher scores indicate worse depression outcomes.
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hamilton Depression Rating Scale
大体时间：Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Change in short-term depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17).
The total score ranges from 0 to 52, with higher scores indicating more severe depression.
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Positive and Negative Affect Schedule
大体时间：Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Change in short-term positive and negative affect measured by the Positive and Negative Affect Schedule (PANAS).
The PANAS consists of two 10-item subscales: Positive Affect (PA) and Negative Affect (NA), each with a total score ranging from 10 to 50.
For the PA subscale, higher scores indicate better outcomes (greater positive affect).
For the NA subscale, higher scores indicate worse outcomes (greater negative affect).
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Maudsley Three-Item Visual Analogue Scale
大体时间：Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Change in short-term subjective mood state measured by the Maudsley Three-Item Visual Analogue Scale.
The scale consists of three separate visual analogue items (e.g., happiness, anxiety, depression), each scored from 0 to 100 mm (0 = absence of the feeling, 100 = extreme feeling).
For the happiness item, a higher score indicates a better outcome.
For the anxiety and depression items, higher scores indicate worse outcomes.
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年5月10日
首先提交符合 QC 标准的
2026年5月22日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月22日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.