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

Refractory Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153812
• Other study ID #: VNS20190620
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: October 2019
• Source: Xijing Hospital
• Contact: Wang Huaning
• Phone: 13609161341
• Email: xskzhu[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 30, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Refractory Depression

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety	The incidence of adverse events and serious adverse events at each visit	12months
Primary	HAMD-17	HAMD-17 score reduction rate at 6 months of follow-up compared to baseline	6 months
Secondary	HAMD-17	HAMD-17 score reduction rate at 3,12 months of follow-up compared to baseline	12months
Secondary	MADRS	Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline	12months
Secondary	IDS-SR	Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline	12months
Secondary	CGI	Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline	12months
Secondary	PSQI	Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline	12months