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.
1. Drug +VNS stimulation group: both VNS and escitalopram oxalate tablets were treated for 2 months. VNS stimulation was treated once a day for 30 minutes at the intensity of 1-2mA. Drug treatment: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day 2. Drug + sham stimulation group: the patients were treated with escitalopram oxalate tablets and sham VNS for 2 months. Sham VNS stimulation: the sham stimulation device automatically stops after 30 seconds of stimulation. Drug treatment was the same as the above group. 3. Drug group: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day without VNS stimulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
90
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.
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.
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGChanges 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
Time frame: From the baseline to the week 8
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
Time frame: From baseline to week 4
Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8
Changes of MADRS SDS scale scores from baseline after the end of treatment at week 4 and week 8
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline to week 4 and week 8
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