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

NCT ID: NCT04153812

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-05-30

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.

Conditions

Refractory Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

vagus nerve stimulation

Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital

Xian, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Huaning

Role: CONTACT

xskzhu@fmmu.edu.cn

13609161341

Chen Yihuan

Role: CONTACT

chenyh47@fmmu.edu.cn

Facility Contacts

Wang Huaning

Role: primary

Other Identifiers

VNS20190620

Identifier Type: -

Identifier Source: org_study_id