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

Phase 1

• Conditions: Refractory Depression

• Registration Number: NCT04153812
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-11-01
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Primary Completion: 2021-10-01
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xian, Shanxi, China