NCT04727229已完成4 期
Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility, Recruitment, Acceptability, Safety,
研究概览
简要总结
This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years of age
- •Major depressive disorder without psychotic symptoms according to DSM-5 criteria
- •Hamilton Depression Rating Scale (HAMD)>17
- •Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •Failure of at least two trials of antidepressant therapy during the current episode
- •Capacity to provide informed consent
排除标准
- •Depression secondary to stroke, cancer or other severe medical illness
- •Major Depressive Episode in people with Bipolar Disorder.
- •Post-Traumatic Stress Disorder (PTSD)
- •Acute suicidality defined as score ≥3 on HAMD item 3
- •Previous electroconvulsive therapy
- •Known history of intolerance of hypersensitivity to local anesthetic
- •Current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria
- •Unwilling to maintain current antidepressant regimen.
- •A clinical finding/condition that is unstable or that, in the opinion of the investigator(s) would negatively be affected by an SGB (e.g. movement disorder where patient is unable to lie still for injection or anatomical variants making an SGB impractical).
研究组 & 干预措施
Bupivacaine Hydrochloride
Experimental
Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.
干预措施: Bupivacaine Hydrochloride (Drug)
Normal Saline Solution
Placebo Comparator
Injection of Normal Saline near the stellate ganglion
干预措施: Normal Saline (Drug)
结局指标
主要结局
Feasibility, Recruitment, Acceptability, Safety,
时间窗: 1 year
Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events
次要结局
- Change in the symptoms of depression(6 weeks)
研究者
研究点 (1)
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