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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Major Depressive Disorder
• Intervention / Treatment: Device: Transcutaneous electrical vagus nerve stimulation; Drug: drug treatment; Device: Sham vagus nerve stimulation

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huaning Wang; Phone Number: 13609161341; Email: xskzhu@fmmu.edu.cn
• Study Contact Backup: Name: Yihuan Chen; Email: chenyh47@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug treatment and active VNS; At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.	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.; Other Names: VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.; Drug: drug treatment; Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
Sham Comparator: drug treatment and sham VNS; It received oxacillin oxalate tablets and sham VNS for 2 months.	Drug: drug treatment; Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg; 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.
Other: drug treatment; The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.	Drug: drug treatment; Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Hamd-17 Scale Scores from Baseline to Week 4	Changes of hamd-17 scale scores from baseline to the end of treatment at week 4	From baseline to week 4
Changes of MADRS Scale and SDS Scale Score 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	From baseline to week 4 and week 8
The Clinical Improvement Rate at Week 4 and Week 8	Clinical improvement rates at week 4 and 8 (50% reduction in hamd-17 or MADRS from baseline)	From baseline to week 4 and week 8
The Remission Rate after 8 Weeks' Treatment	Hamd-17 or MADRS scores are less than or equal to 7	From baseline to week 8
Changes of Cytokines 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	From baseline to week 4 and week 8

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Jin Sun, Xidian University, School of Life Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 82554333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No