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

NCT ID: NCT04037111

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2021-12-31

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

Conditions

Major Depressive Disorder; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

drug treatment and active VNS

At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.

Group Type: EXPERIMENTAL

Transcutaneous electrical vagus nerve stimulation

Intervention Type: DEVICE

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.

drug treatment

Intervention Type: DRUG

Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

drug treatment and sham VNS

It received oxacillin oxalate tablets and sham VNS for 2 months.

Group Type: SHAM_COMPARATOR

Sham vagus nerve stimulation

Intervention Type: DEVICE

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 treatment

Intervention Type: DRUG

Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

drug treatment

The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.

Group Type: OTHER

drug treatment

Intervention Type: DRUG

Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

drug treatment

Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

Intervention Type: DRUG

Other Intervention Names

VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Sun

Role: PRINCIPAL_INVESTIGATOR

Xidian University, School of Life Science and Technology

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huaning Wang

Role: CONTACT

xskzhu@fmmu.edu.cn

13609161341

Yihuan Chen

Role: CONTACT

chenyh47@fmmu.edu.cn

Facility Contacts

Huaning Wang

Role: primary

Other Identifiers

82554333

Identifier Type: -

Identifier Source: org_study_id