Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | 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. |
|
| Sham Acupuncture Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale Score | Change in short-term depressive symptom severity measured by the Montgomery-Ã…sberg Depression Rating Scale (MADRS), a 10-item scale with a total score ranging from 0 to 60. Higher scores indicate worse depression outcomes. | Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | 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. | Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunling Fan, M.D. | Contact | +86 10 89926000 | fanjingzi1@126.com | |
| YU MA, M.D. | Contact | +86 10 89926000 | mayu@tsinghua.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2026 | May 22, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2026 | May 22, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Acupuncture | Procedure | Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects. |
|
| Positive and Negative Affect Schedule |
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). |
| Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture |
| Maudsley Three-Item Visual Analogue Scale | 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. | Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture |