NCT03923361撤回2 期
Neural and Antidepressant Effects of Propofol (Phase 2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
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
- •Age 18-55
- •Diagnosis of major depressive disorder or bipolar disorder
- •Current moderate-to-severe depressive episode
- •Episode duration more than 2 months and less than 5 years
- •Failure of at least 2 adequate antidepressant medication trials within the past 2 years
- •Body mass index < 40
- •16-item Quick Inventory of Depressive Symptomatology, self-rated > 10
排除标准
- •Contraindication to propofol or midazolam
- •Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
- •Symptomatic coronary artery disease or heart failure
- •Poorly controlled hypertension or diabetes
- •Abnormal kidney or liver function
- •Pregnant or breast feeding
- •Traumatic brain injury or significant neurologic signs (past year)
- •Substance use disorder (past year)
- •Obsessive compulsive disorder (current)
- •Post-traumatic stress disorder (current)
- •Schizophrenia-spectrum disorder (lifetime)
- •Neurocognitive disorder (current)
- •Personality disorder as a current focus of treatment
- •ECT within the past 3 months
- •Inappropriate for ECT, or poor response to ECT within the past 5 years
- •Incompetent to provide consent
研究组 & 干预措施
Propofol
Experimental
干预措施: Diprivan (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: 3 weeks after baseline
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score \< 10 Response defined as decrease of total score from baseline \> 50%
次要结局
未报告次要终点
研究者
Brian Mickey
Principal Investigator
University of Utah
研究点 (1)
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