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Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression

Primary Purpose

Refractory Depression

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
vagus nerve stimulation
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
  2. age 18-65; Male or female
  3. the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
  4. HAMD-17 score> 17 was at baseline

Exclusion Criteria:

  1. pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
  2. a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
  3. patients currently at serious risk of suicide
  4. prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
  5. patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
  6. accept other clinical trials
  7. patients requiring systemic mri after implantation

Sites / Locations

  • Xijing HospitalRecruiting

Outcomes

Primary Outcome Measures

HAMD-17
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline

Secondary Outcome Measures

HAMD-17
HAMD-17 score reduction rate at 3，12 months of follow-up compared to baseline
MADRS
Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline
IDS-SR
Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline
CGI
Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline
PSQI
Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline

Full Information

First Posted
November 3, 2019
Last Updated
November 3, 2019
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04153812
Brief Title
Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
Official Title
Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
May 30, 2022 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials
Detailed Description
This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
vagus nerve stimulation
Intervention Description
Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.
Primary Outcome Measure Information:
Title
HAMD-17
Description
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HAMD-17
Description
HAMD-17 score reduction rate at 3，12 months of follow-up compared to baseline
Time Frame
12months
Title
MADRS
Description
Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline
Time Frame
12months
Title
IDS-SR
Description
Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline
Time Frame
12months
Title
CGI
Description
Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline
Time Frame
12months
Title
PSQI
Description
Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline
Time Frame
12months
Other Pre-specified Outcome Measures:
Title
safety
Description
The incidence of adverse events and serious adverse events at each visit
Time Frame
12months

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: patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants) age 18-65; Male or female the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes HAMD-17 score> 17 was at baseline Exclusion Criteria: pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms patients currently at serious risk of suicide prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy) accept other clinical trials patients requiring systemic mri after implantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Huaning
Phone
13609161341
Email
xskzhu@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yihuan
Email
chenyh47@fmmu.edu.cn
Facility Information:
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Huaning

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression

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