NCT02935647已完成1 期
Burst Suppression Anesthesia for Treatment of Severe Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.
详细描述
Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression
- •Failed at least 2 anti-depressant treatments and no ECT in past 6 months
- •Age between 18-55 years
- •BMI < 35
- •Hamilton Rating Scale for Depression (HSRD) score > 18
- •Quick Inventory of Depression Scale (QIDS) score > 10.
排除标准
- •• Diagnosis of primary psychotic disorder, dysthymia, or personality disorder
- •Significant pre-morbid cognitive impairment
- •Hypertension and current use of ACE inhibitor or AR blocker medications
- •Symptomatic coronary artery disease or congestive heart failure
- •History of transient ischemic or neurologic signs during the past year
- •History of or susceptibility to malignant hyperthermia
- •Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
- •Diabetes requiring insulin
- •Poor kidney function
- •Chronic use of benzodiazepines or opioids
- •Individuals incompetent to provide consent (e.g. catatonic, psychotic).
研究组 & 干预措施
Propofol
Experimental
Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken.
干预措施: Diprivan (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: 3 weeks
次要结局
- Quick Inventory of Depressive Symptoms(3 weeks)
研究者
Brian Mickey
Principal Investigator
University of Utah
研究点 (1)
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