Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Brief Edinburg Depression Scale (BEDS) score
研究概览
简要总结
Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).
MD is a frequent complication in patients who are diagnosed with advanced cancer.
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
- Double (Participant, Care Provider)
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
- •Age: 18 to 65 years of age
- •Sex: Male or female
- •Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- •Palliative stage cancer diagnosis (advanced-disease stage)
- •Who can read and write in spanish
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Karnofsky ≥ 50
- •Palliative prognostic index A
- •Not currently undergoing systemic oncologic treatment
- •Patients who agree to participate in the study by signing an informed consent.
排除标准
- •Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
- •Magnetic resonance or computerized tomography with major structural alterations.
- •Pregnant or breastfeeding women.
- •Patients with hypersensitivity to ketamine
- •Cardiac insufficiency
- •Patients with a history of psychosis
- •Patients with first-degree relatives with a history of psychosis
- •Patients with uncontrolled glaucoma
- •Current neurological illness
研究组 & 干预措施
Ketamine
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
干预措施: Ketamine (Drug)
Placebo
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Brief Edinburg Depression Scale (BEDS) score
时间窗: 3 weeks
Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.
次要结局
未报告次要终点
研究者
Oscar Raúl Rodríguez Mayoral
Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico)
Instituto Nacional de Cancerologia de Mexico