Major Depressive DisorderNCT04037111
Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms
A study testing Transcutaneous electrical vagus nerve stimulation and drug treatment in people with Major Depressive Disorder and Rheumatoid Arthritis, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Rheumatoid Arthritis
- What is being tested?
- Transcutaneous electrical vagus nerve stimulation and drug treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- MRI scan taboos and high-risk groups;
- Pregnancy, breastfeeding or planning for pregnancy during the trial;
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
Yihuan Chen contact
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Huaning Wang
About this study
Official title: Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms
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.
Read the 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
- Conditions
- Major Depressive Disorder, Rheumatoid Arthritis
- Being tested
- Transcutaneous electrical vagus nerve stimulation, Sham vagus nerve stimulation, drug treatment
- Medical subject headings
- Depressive Disorder, Major, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical vagus nerve stimulationDevice
Also called VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.
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.
Sham vagus nerve stimulationDevice
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.
drug treatmentDrug
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
| Study group | Role | What they receive |
|---|---|---|
| drug treatment and active VNS | Experimental | At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months. Receives: Device: Transcutaneous electrical vagus nerve stimulation; Drug: drug treatment |
| drug treatment and sham VNS | Sham comparator | It received oxacillin oxalate tablets and sham VNS for 2 months. Receives: Device: Sham vagus nerve stimulation; Drug: drug treatment |
| drug treatment | Other | The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation. Receives: Drug: drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the baseline to the week 8
Secondary outcomes (5)
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
Measured: From baseline to 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
Measured: From baseline to 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)
Measured: From baseline to week 4 and week 8
The Remission Rate after 8 Weeks' Treatment
Hamd-17 or MADRS scores are less than or equal to 7
Measured: From baseline to week 8
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
Measured: From baseline to week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start23 Jul 2019
- Primary completionJan 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Sun, Principal investigator, Xidian University, School of Life Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037111
- Sponsor's protocol ID
- 82554333
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms
- ClinicalTrials.gov ID
- NCT04037111
- Acronym / sponsor ID
- 82554333
- Conditions
- Major Depressive Disorder, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| drug treatment and active VNS | Experimental | Device: Transcutaneous electrical vagus nerve stimulation, Drug: drug treatmentAt the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months. |
| drug treatment and sham VNS | Sham comparator | Device: Sham vagus nerve stimulation, Drug: drug treatmentIt received oxacillin oxalate tablets and sham VNS for 2 months. |
| drug treatment | Other | Drug: drug treatmentThe dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical vagus nerve stimulationAlso: VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.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. | Device | drug treatment and active VNS |
| Sham vagus nerve stimulationThe 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. | Device | drug treatment and sham VNS |
| drug treatmentEscitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg | Drug | drug treatment, drug treatment and active VNS, drug treatment and sham VNS |
Primary outcome
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
5 secondary outcomes
Changes of Hamd-17 Scale Scores from Baseline to Week 4
Time frame: From baseline to week 4
Changes of MADRS Scale and SDS Scale Score from Baseline to Week 4 and Week 8
Time frame: From baseline to week 4 and week 8
The Clinical Improvement Rate at Week 4 and Week 8
Time frame: From baseline to week 4 and week 8
The Remission Rate after 8 Weeks' Treatment
Time frame: From baseline to week 8
Changes of Cytokines from Baseline to Week 4 and Week 8
Time frame: From baseline to week 4 and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yihuan Chen contact
Jin Sun principal investigator
Xidian University, School of Life Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical vagus nerve stimulation and drug treatment in people with Major Depressive Disorder and Rheumatoid Arthritis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaning Wang (13609161341, xskzhu@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Hamd-17 Scale Scores From Baseline to Week 8 (time frame: From the baseline to the week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.