Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.
详细描述
Rapid-onset antidepressants could have important clinical impact if their benefits extended to Emergency Department (ED) patients. We hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (IV) ketamine in depressed ED patients who presented with suicide ideation (SI).
The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate. The article misrepresents both the protocol-specified doses and the actual delivered doses of ketamine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (>18yrs) presenting to the Emergency department with symptoms of depression and/or suicide ideation (MADRS>30) with ability to give informed consent.
- •medically stable
排除标准
- •psychosis, bipolar, or other significant physical or mental illness
- •pregnancy
- •non-voluntary status
- •urine drug screen positive for drugs of abuse
研究组 & 干预措施
Ketamine
Patients were administered a single sub-anaesthetic i.v. bolus of ketamine (0.2 mg/kg over 1-2 min) in the ED, with continuous monitoring of vital signs, adverse events and psychotomimetic side-effects for 4 h post-administration.
干预措施: ketamine (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: 40, 80, 120, 240 minutes after administration of drug
The MADRS measures mood (depression) and item 10 measures suicide ideation.
次要结局
- recruitment success and retention of subjects in the ER(initial recruitment of eligible subjects in the ER and for two weeks after administration of drug)