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

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

Study Overview

• Status: Unknown
• Conditions: Refractory Depression
• Intervention / Treatment: Device: vagus nerve stimulation

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xian, Shanxi, China
      • Recruiting
      • Xijing Hospital
      • Contact: Wang Huaning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAMD-17	HAMD-17 score reduction rate at 6 months of follow-up compared to baseline	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	The incidence of adverse events and serious adverse events at each visit	12months

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: VNS20190620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No