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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Major Depressive Disorder; Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04037111

82554333

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

drug treatment and active VNS

Experimental group

Description:

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

Treatment:

Drug: drug treatment

Device: Transcutaneous electrical vagus nerve stimulation

drug treatment and sham VNS

Sham Comparator group

Description:

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

Treatment:

Drug: drug treatment

Device: Sham vagus nerve stimulation

drug treatment

Other group

Description:

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

Treatment:

Drug: drug treatment