Status:
UNKNOWN
Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms
Lead Sponsor:
Xijing Hospital
Conditions:
Major Depressive Disorder
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 stimul...
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: th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04037111
Start Date
July 23 2019
End Date
December 1 2021
Last Update
August 20 2019
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032