Endogenous Opioid Modulation by Ketamine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale at 24 hours, change from baseline
研究概览
简要总结
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
详细描述
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age 18-65
- •DSM-5 major depressive disorder
- •Current moderate-to-severe, treatment-resistant, depressive episode
- •Patient Health Questionnaire (PHQ-9) total score ≥ 10
- •PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
- •PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
- •Medical documentation of depression for at least 2 months
- •Inadequate response to at least one adequate antidepressant medication trial in the current episode
排除标准
- •Current episode duration >5 years
- •Moderate-to-severe DSM-5 substance use disorder (past year)
- •Cognitive disorder (past year)
- •Post-traumatic stress disorder (past year)
- •Obsessive compulsive disorder (past year)
- •Personality disorder (past year)
- •Positive urine drug screen
- •Psychotic symptoms
- •Significant neurologic disorder or injury
- •Breastfeeding or pregnancy
- •Imminent suicide risk
- •Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
- •Other unstable psychiatric or medical condition requiring a higher level of care
- •Contraindication to ketamine, MRI, or PET
研究组 & 干预措施
Ketamine
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
干预措施: Ketamine Hydrochloride (Drug)
Placebo
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
干预措施: Normal saline (Other)
结局指标
主要结局
Hamilton Depression Rating Scale at 24 hours, change from baseline
时间窗: 24 hr
total score on the 17-item Hamilton Depression Rating Scale
次要结局
未报告次要终点
研究者
Brian Mickey
Principal Investigator
University of Utah