Clinical trial NCT04037111: Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms
Official title: Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Rheumatoid Arthritis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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: 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

Eligibility 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.

Primary outcomes:
measure: Changes of Hamd-17 Scale Scores From Baseline to Week 8
timeFrame: From the baseline to the week 8
Secondary outcomes:
measure: Changes of Hamd-17 Scale Scores from Baseline to Week 4
timeFrame: From baseline to week 4
measure: Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8
timeFrame: From baseline to week 4 and week 8
measure: The Clinical Improvement Rate at Week 4 and Week 8
timeFrame: From baseline to week 4 and week 8
measure: The Remission Rate after 8 Weeks' Treatment
timeFrame: From baseline to week 8
measure: Changes of Cytokines from Baseline to Week 4 and Week 8
timeFrame: From baseline to week 4 and week 8
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xidian University, School of Life Science and Technology
name: Jin Sun
role: PRINCIPAL_INVESTIGATOR
References: