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| ID | Type | Description | Link |
|---|---|---|---|
| 21Y11921000 | Other Grant/Funding Number | Shanghai science and techonology committe | |
| 21ZR1449300 | Other Grant/Funding Number | Natural Science Foundation of Shanghai |
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We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham-acupuncture/placebo-pill | Sham Comparator | sham-acupuncture protocol plus escitalopram placebo |
|
| sham-acupuncture/escitalopram | Active Comparator | sham-acupuncture protocol plus escitalopram |
|
| active acupuncture/placebo-pill | Active Comparator | acupuncture protocol plus escitalopram placebo |
|
| active acupuncture/escitalopram | Experimental | acupuncture protocol plus escitalopram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include DU20(Baihui) and SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation. |
| Measure | Description | Time Frame |
|---|---|---|
| HDRS-17 scale | the change in the HDRS-17 score | from baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck depression inventory scale | the change in the Beck depression inventory score | from baseline to 10 weeks |
| The CGI(Clinical Global Impression) scale | the change in the CGI |
| Measure | Description | Time Frame |
|---|---|---|
| BDNF | serum BDNF level | at baseline and 10 week |
| IL18/IL-1β | serum IL18/IL-1β level | at baseline and 10 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenxiang Han, Dr. | Contact | +8617701767768 | hanxiang798007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenxiang Han, Dr | Shanghai Seventh People's Hospital, Shanghai University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianhua Chen | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260834 | Derived | Yang K, Tiwari S, Liu D, Xu Q, Qi L, Zhu Y, Jiang L, Zouqin H, Wong J, Chen J, Han Z. Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): protocol for a factorial randomised controlled trial. BMJ Open. 2024 Sep 10;14(9):e091214. doi: 10.1136/bmjopen-2024-091214. |
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The paper will be published. Anonymized demographic and clinical data as well as anonymized curated (i.e., after preprocessing and quality control) cytokine levels.
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ResMan IPD
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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 |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011437 | Propylamines |
| D000588 | Amines |
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|
|
| escitalopram | Other | Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks. |
|
| sham-acupuncure | Other | In the sham acupuncture group, superficial skin penetration (2 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group. |
|
| escitalopram placebo | Other | Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks. |
|
| from baseline to 10 weeks |
| The GAD-7(General Anxiety Disorder) scale | the change in the GAD-7 | from baseline to 10 weeks |
| The Mini-Mental State Examination (MMSE) scale | the change in the MMSE | from baseline to 10 weeks |
| fMRI | functional MRI | at baseline and 10 week |
| Zhenxiang Han | Shanghai | Shanghai Municipality | 200137 | China |
|
| Zouqing Huang | Shanghai | Shanghai Municipality | China |
|
| D009930 |
| Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |