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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Citalopram; Dexetimide

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.