Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 3, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedNovember 6, 2019
October 1, 2019
1.9 years
November 3, 2019
November 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
HAMD-17
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
6 months
Secondary Outcomes (5)
HAMD-17
12months
MADRS
12months
IDS-SR
12months
CGI
12months
PSQI
12months
Other Outcomes (1)
safety
12months
Interventions
Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xian, Shanxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2019
First Posted
November 6, 2019
Study Start
November 1, 2019
Primary Completion
October 1, 2021
Study Completion
May 30, 2022
Last Updated
November 6, 2019
Record last verified: 2019-10