Back to resultsClinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms
Primary Purpose
Major Depressive Disorder, Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical vagus nerve stimulation
Sham vagus nerve stimulation
drug treatment
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder
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.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
drug treatment and active VNS
drug treatment and sham VNS
drug treatment
Arm Description
At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
It received oxacillin oxalate tablets and sham VNS for 2 months.
The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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)
The Remission Rate after 8 Weeks' Treatment
Hamd-17 or MADRS scores are less than or equal to 7
Changes of Cytokines from Baseline to Week 4 and Week 8
Changes in cytokines such as TNF-α, IL-γ, IL-4, IL-8 and IL-10 from baseline to the end of treatment after week 4 and week 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04037111
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drug treatment and active VNS
Arm Type
Experimental
Arm Description
At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
Arm Title
drug treatment and sham VNS
Arm Type
Sham Comparator
Arm Description
It received oxacillin oxalate tablets and sham VNS for 2 months.
Arm Title
drug treatment
Arm Type
Other
Arm Description
The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical vagus nerve stimulation
Other Intervention Name(s)
VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham vagus nerve stimulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
drug treatment
Intervention Description
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
Primary Outcome Measure Information:
Title
Changes of Hamd-17 Scale Scores From Baseline to Week 8
Description
After 8 weeks of treatment, the rate of hamd-17 scale score was decreased compared with the baseline
Time Frame
From the baseline to the week 8
Secondary Outcome Measure Information:
Title
Changes of Hamd-17 Scale Scores from Baseline to Week 4
Description
Changes of hamd-17 scale scores from baseline to the end of treatment at week 4
Time Frame
From baseline to week 4
Title
Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8
Description
Changes of MADRS SDS scale scores from baseline after the end of treatment at week 4 and week 8
Time Frame
From baseline to week 4 and week 8
Title
The Clinical Improvement Rate at Week 4 and Week 8
Description
Clinical improvement rates at week 4 and 8 (50% reduction in hamd-17 or MADRS from baseline)
Time Frame
From baseline to week 4 and week 8
Title
The Remission Rate after 8 Weeks' Treatment
Description
Hamd-17 or MADRS scores are less than or equal to 7
Time Frame
From baseline to week 8
Title
Changes of Cytokines from Baseline to Week 4 and Week 8
Description
Changes in cytokines such as TNF-α, IL-γ, IL-4, IL-8 and IL-10 from baseline to the end of treatment after week 4 and week 8
Time Frame
From baseline to week 4 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huaning Wang
Phone
13609161341
Email
xskzhu@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yihuan Chen
Email
chenyh47@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Sun
Organizational Affiliation
Xidian University, School of Life Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaning Wang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms
We'll reach out to this number within 24 hrs