Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 主要终点
- Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.
详细描述
The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 21-65 years old
- •Current major depressive disorder without psychotic features by DSM-5
- •Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
- •Current alcohol use disorder by DSM-5
- •Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
- •Abstinence from alcohol drinking for > 5 days prior to ketamine infusion
- •Able to provide written informed consent
排除标准
- •Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
- •Current or past history of psychotic features or psychotic disorder
- •Current or past history of delirium or dementia
- •Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)
- •Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
- •Imminent suicidal or homicidal risk
- •Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
- •Positive opioid or illicit drug screen test (except marijuana)
- •Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
- •Liver enzymes that are three times higher than the upper limit of normal
研究组 & 干预措施
Ketamine + Naltrexone
Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).
干预措施: Ketamine + Naltrexone (Drug)
结局指标
主要结局
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Day 21
Response is defined as a ≥ 50% improvement from baseline in MADRS scores. The MADRS has a total range of 0-60. Higher scores represent a worse outcome (i.e., more depression).
次要结局
- Obsessive Compulsive Drinking Scale (OCDS)(Day 21)
研究者
Gihyun Yoon
Principal Investigator
VA Connecticut Healthcare System