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Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | 5 sessions of acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the acupoints. Each session will last 30 minutes. |
|
| sham acupuncture | Sham Comparator | 5 sessions of sham acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on non-acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the non-acupoints. Each session will last 30 minutes. |
|
| waiting-list | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the acupoints on body to treat diseases. |
| Measure | Description | Time Frame |
|---|---|---|
| score of Hamilton Depression Rating Scale-24 | Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24 | change from baseline to 4 weeks after intervention, after follow-up(4 week) |
| Measure | Description | Time Frame |
|---|---|---|
| score of self-rating depression scale | Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on self-rating depression scale (SDS) | baseline, after intervention(4 week), after follow-up(4 week) |
| score of Hamilton Anxiety Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Zheng, PhD | Contact | 18980601861 | zhengzhong1963@163.com | |
| Rongjiang Jin | Contact | cdzyydxjrj@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Huang | Institute of Science and Technology Development, Sichuan University | Study Chair |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on Hamilton Anxiety Rating Scale (HAMA) |
| baseline, after intervention(4 week) , after follow-up(4 week) |
| score of Social Disability Screening Schedule | change of score of Social Disability Screening Schedule (SDSS) | baseline, after intervention(4 week) , after follow-up(4 week) |
| score of Pittsburgh sleep quality index (PSQI) | change of score of Pittsburgh sleep quality index (PSQI) | baseline, after intervention(4 week) , after follow-up(4 week) |
| motor threshold (MT) | motor threshold (MT) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer | baseline, after intervention(4 week) , after follow-up(4 week) |
| Intra-cortical facilitation (ICF) | Intra-cortical facilitation (ICF) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer | baseline, after intervention(4 week) , after follow-up(4 week) |
| cortical resting period (CSP) | cortical resting period (CSP) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer [Time Frame: baseline, after intervention(4 week), after follow-up(4 week)] | baseline, after intervention(4 week) , after follow-up(4 week) |
| intra-cortical inhibition (ICI) | intra-cortical inhibition (ICI) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer | baseline, after intervention(4 week) , after follow-up(4 week) |
| IAPS Evoked Event-related Potentials (ERP) | IAPS Evoked Event-related Potentials (ERP) | baseline, after intervention(4 week), after follow-up(4 week) |
| Evoked Event-related Potentials (ERP) in TMS-EEG | Evoked Event-related Potentials (ERP) in TMS-EEG | baseline, after intervention(4 week), after follow-up(4 week) |
| Adverse events | Adverse events | during intervention(4 week) |