Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
研究概览
简要总结
Depression is common in patients with cancer. Current medications for depression, while effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for cancer patients. In two reported cases, a single dose of ketamine induced rapid and moderately sustained symptom reduction in depression and anxiety with no adverse side effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a randomized, double-blind, placebo-controlled investigation testing whether a single dose of ketamine improves depression and anxiety relative to placebo in patients with cancer.
详细描述
Depression is common in patients with cancer. Current antidepressants, while effective, have an onset of action of at least several weeks. Ketamine has emerged as a drug with promise for cancer patients. It has been shown to potentiate opiate analgesic effects. Single dose parenteral and enteral administration studies in medically healthy treatment-resistant depressed patients have shown rapid relief of symptoms. A recent two patient case series reported a rapid and moderately sustained symptom reduction in depression and anxiety in palliative care patients following a single dose of oral ketamine 0.5 mg/kg, with no adverse effects. Benefit was seen as little as 1 hour after the administration and sustained up to 30 days. These case reports generate hypotheses of efficacy for ketamine in the treatment of depression and anxiety in patients with cancer. This study is a randomized, double-blind, placebo-controlled investigation of these hypotheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with cancer
- •Outpatient status at the time of study entry
- •18 years of age or older
- •Life expectancy of at least 1 month
- •Regular access to a telephone (for safety reasons)
- •Reliable transportation to follow-up visits
- •Caregiver observation available for 24 hours after the dose
- •Histologically-proven malignancy
- •Depression score of >11 on the Hospital Anxiety and Depression Scale (HADS)
- •Provision of informed consent
- •Able to complete the patient questionnaires alone or with assistance
- •Able to speak and read English
- •May receive other psycho-active medications while on the study i.e. opiates, except as defined within the exclusion criteria
- •May receive psychotherapy from an outside provider at the beginning and/or during the course of the study
排除标准
- •Obvious cognitive dysfunction or Mini Mental Status Exam score <20
- •Antidepressants started or dose changed within 8 weeks of the beginning of the study or during the study
- •Benzodiazepines prescribed for psychiatric indications that have been started or dose change within 2 weeks of the beginning of study enrollment
- •Suicidal ideation or a suicide attempt within the last year
- •Patients with current or past psychosis not from delirium
- •Females who are pregnant or nursing
- •Unable to take oral medications
- •Primary or metastatic brain malignancy
- •Gastrointestinal tract obstruction
- •Prior adverse reaction to or other contraindication to ketamine
- •Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, within the last 90 days
研究组 & 干预措施
Ketamine
Single dose of ketamine (0.5 mg/kg)
干预措施: Ketamine (Drug)
Placebo
Single dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
时间窗: Baseline, 120 minutes
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be \>10 for anxiety and \>8 for depression.
Hospital Anxiety Depression Scale- Depression Score (HADS-D)
时间窗: Baseline, 120 minutes
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be \>10 for anxiety and \>8 for depression.
次要结局
未报告次要终点
研究者
Robert P. Bright
Principal Investigator
Mayo Clinic