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This study is expected to include 90 patients with major depressive disorder and rheumatoid arthritis as study subjects.Randomly divided into 3 groups: drug + VNS stimulation group, drug + sham stimulation group and drug group, each group had 30 patients.The treatment period of each group was 8 weeks.Age and sex were matched in all three groups.Scale evaluation and inflammatory factor test were performed before treatment (baseline), at week 4 and week 8 after treatment.Head MRI, evoked potential, and electrocardiogram were performed at baseline and at the end of week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug treatment and active VNS | Experimental | At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months. |
|
| drug treatment and sham VNS | Sham Comparator | It received oxacillin oxalate tablets and sham VNS for 2 months. |
|
| drug treatment | Other | The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical vagus nerve stimulation | Device | The patient received active VNS and escitalopram oxalate tablets for 2 months.When the VNS was stimulated, the two electrodes were vertically attached to the left carotid sinus at 2cm, or the auricular clip electrode was applied to the tragus. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Hamd-17 Scale Scores From Baseline to Week 8 | After 8 weeks of treatment, the rate of hamd-17 scale score was decreased compared with the baseline | From the baseline to the week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Hamd-17 Scale Scores from Baseline to Week 4 | Changes of hamd-17 scale scores from baseline to the end of treatment at week 4 | From baseline to week 4 |
| Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaning Wang | Contact | 13609161341 | xskzhu@fmmu.edu.cn | |
| Yihuan Chen | Contact | chenyh47@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Sun | Xidian University, School of Life Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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|
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| Sham vagus nerve stimulation | Device | The patient received sham VNS.When the VNS was stimulated, the two electrodes were vertically attached to the left carotid sinus at 2cm, or the auricular clip electrode was applied to the tragus. |
|
| drug treatment | Drug | Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg |
|
Changes of MADRS SDS scale scores from baseline after the end of treatment at week 4 and week 8
| From baseline to week 4 and week 8 |
| The Clinical Improvement Rate at Week 4 and Week 8 | Clinical improvement rates at week 4 and 8 (50% reduction in hamd-17 or MADRS from baseline) | From baseline to week 4 and week 8 |
| The Remission Rate after 8 Weeks' Treatment | Hamd-17 or MADRS scores are less than or equal to 7 | From baseline to week 8 |
| Changes of Cytokines from Baseline to Week 4 and Week 8 | Changes in cytokines such as TNF-α, IL-γ, IL-4, IL-8 and IL-10 from baseline to the end of treatment after week 4 and week 8 | From baseline to week 4 and week 8 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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