Keta-Care - Antidepressant and Anxiolytic Effects of Intranasal Ketamine Self-administration in Palliative Care Cancer Patients: an Open-label Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms assessed by the MADRS
研究概览
简要总结
With progression of cancer, patients and their caregivers experience challenging emotional distress, which can make them feel depressed and very anxious.
Patients with advanced cancer often do not have long to live. However, most antidepressants take a long time to act and cause unwanted side effects. There is hence a need for a fast acting antidepressant with fewer unwanted side effects.
Ketamine is an effective and fast acting antidepressant originating from pain treatment, which has few unwanted side effects. It can be taken by a patient as a nasal spray when it is needed.
The idea of treating depression and anxiety in cancer patients in palliative care with ketamine nasal spray is new. How effective ketamine will be at reducing depression and anxiety in patients is unknown . It is also unknown whether this kind of treatment will be safe and practical for palliative care patients.
This study aims to answer these questions. Patients will be treated with a low dose (5 mg) of ketamine nasal spray and then measure its effectiveness, practicality and safety. Questionnaires will be used to measure these outcomes.
If treating depression and anxiety with ketamine nasal spray proves to be effective, practical and safe, then it could help to improve the quality of life for palliative care patients and reduce the burden of their caregivers.
详细描述
With progression of cancer, patients, but also their caregivers, are predisposed to experience challenging emotional distress due to their terminal illness, resulting in depression and anxiety. However, the overall limited survival time and often complex medication regimes complicate a timely and tolerable treatment of these symptoms, when time-consuming psychotherapeutic sessions or classic antidepressant medication with side effects are unfavorable.
Ketamine is an effective and fast acting antidepressant originating from pain treatment, which can be administered non-invasively as easy to handle nasal spray. The possibility of using ketamine as needed, and not necessarily daily as classical antidepressants, limits the occurrence of side effects and has the potential to ease symptom burden in patients as well as caregivers in this vulnerable cohort. Yet, the efficacy and feasibility of intranasal ketamine self-administration in palliative care cancer patients has not been investigated to date.
In the open-label feasibility study proposed here, we aim at assessing the safety, feasibility and efficacy for the treatment of depression and anxiety with low-dose (5 mg per stroke) intranasal ketamine in a population of early palliative care cancer patients in an out-patient setting.
If self-administered nasal ketamine proves efficient and safe in this study population of often neglected palliative care patients, an easy to handle, low-cost and fast-acting drug with lower risk for interactions would be available to ease burden and emotional symptom load, and eventually increase quality of life for patients and caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine
Open-label, flexibly-dosed intranasal ketamine hydrochloride
干预措施: Intranasal ketamine hydrochloride (Drug)
结局指标
主要结局
Change in depressive symptoms assessed by the MADRS
时间窗: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Montgomery- Asberg Depression Scale (MADRS), 10 items, higher values indicate increasing symptom burden and total scores range from 0 to 60.
次要结局
- Change in sleep quality assessed by the PSQI questionnaire (caregivers)(From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks)
- Change in anxiety assessed by the HAM-A questionnaire(From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks)
- Change in quality of life assessed by the QLQ-C30 questionnaire(From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks)
- Change in sleep quality assessed by the PSQI questionnaire(From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks)
- Change in depressive symptoms assessed by the HADS questionnaire(From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks)
- Change in caregiver burden assessed by the ZBS questionnaire (caregivers)(From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks)
- Change in caregiver quality of life assessed by the CarGoQoL questionnaire (caregivers)(From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks)