NCT03410446已完成2 期
A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Greater than 25% of participants achieving a clinical response
研究概览
简要总结
This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.
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
- •Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
- •Males and females ≥ 18 years of age
- •Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
- •Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
- •Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician
排除标准
- •Presence of delirium or suspected delirium
- •Severe hypertension or severe cardiac decompensation
- •Previous stroke history
- •History of intolerability, hypersensitivity or allergy to ketamine
- •Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
- •Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
- •Pregnancy or breastfeeding women
研究组 & 干预措施
Ketamine
Experimental
Three doses of ketamine will be given intranasal:
- Dose 1 will be 50 mg on Day 1
- Dose 2 will be between 50-100 mg on Day 4
- Dose 3 will be between 50-150 mg on Day 7
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Greater than 25% of participants achieving a clinical response
时间窗: Day 8
Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by \>50%
次要结局
未报告次要终点
研究者
研究点 (1)
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