Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
研究概览
简要总结
Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- •Outpatient with sever treatment resistant depression
- •Currently depressed
- •Currently under regular psychiatric care
- •On an aggressive antidepressant regimen, stable for 4 weeks.
排除标准
- •No history of other major psychiatric illness, including bipolar
- •No history of psychosis
- •No history of drug abuse
- •No major medical illness or unstable medical problem
研究组 & 干预措施
Ketamine
Subject will receive 6 infusions of ketamine over three weeks.
干预措施: Ketamine (Drug)
Placebo
Subjects will receive 6 infusions of normal saline over 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
时间窗: up to 4 months
The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.
次要结局
- HDRS-28 Total(up to 5 months)
研究者
Cristina Cusin, MD
Instructor HSM
Massachusetts General Hospital