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

Not Applicable

• Conditions: Major Depressive Disorder; Rheumatoid Arthritis
• Interventions: Device: Transcutaneous electrical vagus nerve stimulation; Device: Sham vagus nerve stimulation; Drug: drug treatment

• Registration Number: NCT04037111
• Lead Sponsor: Xijing Hospital

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

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-23
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-30
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-20
• Primary Completion: 2021-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug treatment and sham VNS	drug treatment	It received oxacillin oxalate tablets and sham VNS for 2 months.
drug treatment and active VNS	Transcutaneous electrical vagus nerve stimulation	At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
drug treatment and active VNS	drug treatment	At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
drug treatment and sham VNS	Sham vagus nerve stimulation	It received oxacillin oxalate tablets and sham VNS for 2 months.
drug treatment	drug treatment	The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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 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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China