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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04037111
• Other study ID #: 82554333
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Xijing Hospital
• Contact: Huaning Wang
• Phone: 13609161341
• Email: xskzhu[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Rheumatoid Arthritis

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The Remission Rate after 8 Weeks' Treatment	Hamd-17 or MADRS scores are less than or equal to 7	From baseline to week 8
Secondary	Changes of Cytokines from Baseline to Week 4 and Week 8	Changes in cytokines such as TNF-a, IL-?, 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