Clinical trial NCT04990687: Vagal Nerve Stimulation for Treatment Resistant Major Depression
Official title: Vagal Nerve Stimulation for Treatment Resistant Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months
timeFrame: 3 months
measure: Number of Participants With Adverse Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Matthew Macaluso, M.D.
role: PRINCIPAL_INVESTIGATOR
References: