NCT04037111

Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms

Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical vagus nerve stimulation	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.
DEVICE	Sham vagus nerve stimulation	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	drug treatment	Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-01-01
• Completion: 2021-12-01
• First posted: 2019-07-30
• Last updated: 2019-08-20

Locations

1 site across 1 country: China