Vagal Nerve Stimulation for Treatment Resistant Major Depression

NCT04990687 | Completed Results DMC FDA Device

• 1 other identifier: IRB-300007636
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to 1) explore whether vagal nerve stimulation (nVNS) using a hand- held non-invasive device (gammaCore™) works to treat depression and 2) to confirm gammaCore™'s safety profile.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months

  Calculated by the Montgomery-Asberg Depression Rating Scale (MADRS): Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60). Snaith, Harrop, Newby, and Teale (1986) proposed the following cut-offs: scores of 0-6 indicate an absence of symptoms; 7-19 represent mild Depression; 20-34 moderate; 35-60 indicate severe Depression.

  3 months

• Number of Participants With Adverse Events

  gammaCore (nVNS) activates the vagus nerve with patented, gentle electrical stimulation. Adverse events were collected for each study participant, and assessed for relatedness to study treatment.

  3 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

Treatment effects will be measured using standard rating scales including the HDRS-17, MADRS, SF-36, CSSR-S, CGI-I, CGI-S, which will be completed at each visit. The following scales will be completed at every other visit following the screening visit: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. At each study visit safety assessments including vital sign assessment and adverse event assessment will be completed. Subjects will also undergo physical examination and an ECG for safety during screening, after 8 weeks of treatment and at the end of 12 weeks of treatment.

Device: gammaCore™

Interventions

gammaCore™ DEVICE

Implantable VNS (iVNS), the electrical stimulation of the nervous system to modulate or modify function, has been FDA approved in the United States since the late 1990s. Implantable VNS therapy has been approved for use in epilepsy and depression. When treating major depression with implanted VNS, the widely held belief is that chronic stimulation is required for therapeutic effect. In trials of implantable VNS in major depression, more patients respond at 12 months than at 3 months. Once depressed patients respond to VNS, the effects have been demonstrated to continue for up to five years with continued stimulation. This finding suggests that VNS gradually changes brain function through neuroplasticity.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old
• Sufficient fluency in English to understand testing procedures and provide written informed consent
• A Hamilton Depression Rating Scale total score greater than or equal 18
• A DSM 5 diagnosis of MDD based on the MINI

You may not qualify if:

• Evidence of alcohol or other substance use disorder in the past 3 months
• For females: current pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy test at screening).
• Depressed patients who have failed at least one adequate antidepressant trial during the current depressive episode based on the ATRQ.
• Diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, psychotic disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive task due to neurological conditions
• Systolic blood pressure \< 150 and/or diastolic blood pressure \< 90 at screening
• Post-partum state (being within 2 months of delivery or miscarriage)
• Imminent suicide or homicide risk as determined by the investigator
• Being treated with one of the following medications: benzodiazepines or other CNS depressants.
• No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
• If the UDS is positive, the subject would be excluded if, in the opinion of the investigator, the positive UDS meant the subject has an active substance use disorder.
• Patients with prior exposure to VNS therapy whether using an implantable or external device will be excluded.
• An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Samantha White
• Organization: UAB

swwhite@uabmc.edu

205-934-1989

Study Officials

• Matthew Macaluso, M.D.

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bee McWane Reid Professor, Department of Psychiatry and Behavioral Neurobiology

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 4, 2021
• Study Start: January 1, 2022
• Primary Completion: September 8, 2023
• Study Completion: April 3, 2024
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)