Vagal Nerve Stimulation for Treatment Resistant Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: gammaCore™

• Registration Number: NCT04990687
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

The study will be up to 7 visits, which will occur for up to a 6 month period. The first visit is a screening visit, which will take about one hour to determine eligibility. If participants are eligible, participants will be scheduled for a baseline visit and 6 monthly visits to determine the antidepressant effects and possible side effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-04
• Study Start: 2022-01-01
• Primary Completion: 2023-09-08
• Study Completion: 2024-04-03
• Results First Submitted: 2024-04-13
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Results First Posted: 2024-07-01
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

1. Evidence of alcohol or other substance use disorder in the past 3 months
2. For females: current pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy test at screening).
3. Depressed patients who have failed at least one adequate antidepressant trial during the current depressive episode based on the ATRQ.
4. 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
5. Systolic blood pressure < 150 and/or diastolic blood pressure < 90 at screening
6. Post-partum state (being within 2 months of delivery or miscarriage)
7. Imminent suicide or homicide risk as determined by the investigator
8. Being treated with one of the following medications: benzodiazepines or other CNS depressants.
9. No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
10. Any of the following disorders are exclusionary: Rheumatoid arthritis; Lupus erythematosus; Autoimmune hepatitis; Autoimmune peripheral neuropathy; Autoimmune pancreatitis; Behcet's disease; Crohn's disease; Autoimmune glomerulonephritis; Grave's disease; Guillain-Barre syndrome; Hashimoto's thyroiditis; Autoimmune polymyositis or polymyalgia; Myasthenia gravis; Narcolepsy; Polyarteritis nodosa; Scleroderma; Sjogren's syndrome; Transverse myelitis; Wegener's granulomatosis; History of seizures (only childhood febrile seizures are allowed)
11. The presence of clinically significant laboratory findings in the opinion of the investigator including, but not limited to, clinically significant anemia or transaminase elevation is considered exclusionary.
12. 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.
13. Patients with prior exposure to VNS therapy whether using an implantable or external device will be excluded.
14. An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
15. A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
16. An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
17. Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
18. Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
19. Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	gammaCore™	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.

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months	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.
Number of Participants With Adverse Events	3 months	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.

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States