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

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ClinicalTrials.gov Identifier: NCT04037111
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Rheumatoid Arthritis Device: Transcutaneous electrical vagus nerve stimulation Device: Sham vagus nerve stimulation Drug: drug treatment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: drug treatment and active VNS
At the same time, actice VNS, escitalopram oxalate tablets were treated for 2 months.
Device: Transcutaneous electrical vagus nerve stimulation
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.
Other Name: VNS stimulated once a day for 30 minutes each time with a stimulating intensity of 1-2 mA.

Drug: drug treatment
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

Sham Comparator: drug treatment and sham VNS
It received oxacillin oxalate tablets and sham VNS for 2 months.
Device: Sham vagus nerve stimulation
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: drug treatment
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg

drug treatment
The dose of escitalopram oxalate tablets was maintained at 10-20mg/ day without VNS stimulation.
Drug: drug treatment
Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes of Hamd-17 Scale Scores from Baseline to Week 4 [ Time Frame: From baseline to week 4 ]
    Changes of hamd-17 scale scores from baseline to the end of treatment at week 4

  2. 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 ]
    Changes of MADRS SDS scale scores from baseline after the end of treatment at week 4 and week 8

  3. The Clinical Improvement Rate at Week 4 and Week 8 [ Time Frame: From baseline to week 4 and week 8 ]
    Clinical improvement rates at week 4 and 8 (50% reduction in hamd-17 or MADRS from baseline)

  4. The Remission Rate after 8 Weeks' Treatment [ Time Frame: From baseline to week 8 ]
    Hamd-17 or MADRS scores are less than or equal to 7

  5. Changes of Cytokines from Baseline to Week 4 and Week 8 [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037111


Contacts
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Contact: Huaning Wang 13609161341 xskzhu@fmmu.edu.cn
Contact: Yihuan Chen chenyh47@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Huaning Wang         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Jin Sun Xidian University, School of Life Science and Technology

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT04037111     History of Changes
Other Study ID Numbers: 82554333
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents