N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
研究概览
简要总结
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).
This is an open-label study (pilot).
详细描述
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.
Total duration of the study is 5 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with severe treatment-resistant MDD
- •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 illnesses, including bipolar disorder
- •No history of psychosis
- •No history of drug abuse
- •No major medical illness or unstable medical conditions
研究组 & 干预措施
Ketamine IV
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
干预措施: Ketamine (Drug)
结局指标
主要结局
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
时间窗: Weekly for total duration of 4 months
Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
次要结局
未报告次要终点
研究者
Cristina Cusin, MD
Instructor HMS
Massachusetts General Hospital