Vagal Nerve Stimulation for Treatment Resistant Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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)
- •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.
- •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)
- •Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- •Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Matthew Macaluso
Bee McWane Reid Professor, Department of Psychiatry and Behavioral Neurobiology
University of Alabama at Birmingham