Major Depressive Disorder, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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
Interventions
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.
DRUGdrug treatment
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years old, in accordance with DSM-5 diagnostic criteria for major depressive disorder, or meet the diagnostic criteria for rheumatoid arthritis. The major depressive disorder is first or at least not used in the 5 half-life of the drug. Antidepressants, antipsychotics or anticonvulsants. * Hamilton Depression Rating Scale (HAMD) 17 scores over 17 points.
Exclusion criteria
* Brain organic lesions (such as cerebral hemorrhage, large area cerebral infarction, encephalitis, epilepsy); cardiac QTc interval \> 450ms; * Currently or have been diagnosed with other major diseases (such as coronary heart disease, pulmonary heart disease, etc.) * Those who are currently or have been diagnosed with other mental disorders other than major depressive disorder (except for anxiety disorder); * Patients who have a serious risk of suicide or who have had suicide attempts; * Those who are using or have been treated with escitalopram oxalate are not effective; * Those who are participating in or have participated in vagus nerve or transcranial electrical stimulation for less than 3 months; * MRI scan taboos and high-risk groups; * Pregnancy, breastfeeding or planning for pregnancy during the trial; * Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Hamd-17 Scale Scores From Baseline to Week 8 | From the baseline to the week 8 | After 8 weeks of treatment, the rate of hamd-17 scale score was decreased compared with the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Hamd-17 Scale Scores from Baseline to Week 4 | From baseline to week 4 | Changes of hamd-17 scale scores from baseline to the end of treatment at week 4 |
| Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8 | 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 |
| The Clinical Improvement Rate at Week 4 and Week 8 | From baseline to week 4 and week 8 | Clinical improvement rates at week 4 and 8 (50% reduction in hamd-17 or MADRS from baseline) |
| The Remission Rate after 8 Weeks' Treatment | From baseline to week 8 | Hamd-17 or MADRS scores are less than or equal to 7 |
| Changes of Cytokines from Baseline to Week 4 and Week 8 | 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 |
Countries
China
Contacts
Primary ContactHuaning Wang
Backup ContactYihuan Chen
Outcome results
None listed