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

NCT04037111 | Unknown

• 1 other identifier: 82554333
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Changes of Hamd-17 Scale Scores From Baseline to Week 8

  After 8 weeks of treatment, the rate of hamd-17 scale score was decreased compared with the baseline

  From the baseline to the week 8

Secondary Outcomes (5)

• Changes of Hamd-17 Scale Scores from Baseline to Week 4

  From baseline to 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

• The Clinical Improvement Rate at Week 4 and Week 8

  From baseline to week 4 and week 8

• The Remission Rate after 8 Weeks' Treatment

  From baseline to week 8

• Changes of Cytokines from Baseline to Week 4 and Week 8

  From baseline to week 4 and week 8

Study Arms (3)

drug treatment and active VNS

EXPERIMENTAL

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

Device: Transcutaneous electrical vagus nerve stimulation; Drug: drug treatment

drug treatment and sham VNS

SHAM COMPARATOR

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

Device: Sham vagus nerve stimulation; Drug: drug treatment

drug treatment

OTHER

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

Drug: drug treatment

Interventions

Transcutaneous electrical vagus nerve stimulation 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.

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

drug treatment and active VNS

Sham vagus nerve stimulation 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 and sham VNS

drug treatment DRUG

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

drug treatment; drug treatment and active VNS; drug treatment and sham VNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jin Sun

  Xidian University, School of Life Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaning Wang

CONTACT

13609161341; xskzhu@fmmu.edu.cn

Yihuan Chen

CONTACT

chenyh47@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: July 23, 2019
• Primary Completion: January 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)