Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Changes of Hamd-17 Scale Scores From Baseline to Week 8
Study Overview
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.
Detailed Description
- 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
- 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.
- Drug group: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day without VNS stimulation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
drug treatment and active VNS
At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
Intervention: drug treatment (Drug)
drug treatment and active VNS
At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
Intervention: Transcutaneous electrical vagus nerve stimulation (Device)
drug treatment and sham VNS
It received oxacillin oxalate tablets and sham VNS for 2 months.
Intervention: Sham vagus nerve stimulation (Device)
drug treatment and sham VNS
It received oxacillin oxalate tablets and sham VNS for 2 months.
Intervention: drug treatment (Drug)
drug treatment
The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.
Intervention: drug treatment (Drug)
Outcomes
Primary Outcomes
Changes of Hamd-17 Scale Scores From Baseline to Week 8
Time Frame: From the baseline to the week 8
After 8 weeks of treatment, the rate of hamd-17 scale score was decreased compared with the baseline
Secondary Outcomes
- 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)
- Changes of Cytokines from Baseline to 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 Hamd-17 Scale Scores from Baseline to Week 4(From baseline to week 4)