NL-OMON49647招募中2 期
A pilot study on oral esketamine for depression and demoralization in patients with advanced cancer receiving palliative care - Esketamine for depression and demoralization
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Older than 18 years of age;
- •Sufficient understanding of spoken and written Dutch;
- •DSM-5 diagnosis of MDD, first or recurrent episode, ascertained by the Mini
- •International Neuropsychiatry Interview (MINI-plus) and/or demoralization as
- •indicated by a score of 30 on the Demoralization Scale;
- •Advanced malignancy with no curative antitumor treatment possibilities as
- •determined by a physician at the oncology department.
排除标准
- •- Depression with psychotic features, according to the DSM-5;
- •- Previous or comorbid schizophrenia spectrum or other psychotic disorder
- •according to the DSM-5, not including previous MDD with psychotic features;
- •- Comorbid moderate or severe dependence of alcohol or drugs according to the
- •DSM-5, not including tobacco-related and caffeine-related disorders;
- •- Comorbid delirium, according to the DSM-5;
- •- Recent (within the last 4 weeks) or current use of non-prescribed
- •psychoactive compounds, including cannabis and Saint John*s wort;
- •- Electroconvulsive therapy (ECT) sessions or antidepressant treatment changes
- •planned for the period of the study;
- •- Current use of benzodiazepines and benzodiazepine-like agents (zolpidem,
- •zopiclone) in excess of 2 mg lorazepam or an equivalent per day;
- •- Current use of ketamine;
- •- Mental incompetence to provide informed consent;
- •- Presence of any contra-indication for ketamine use. Ketamine is
- •contra-indicated in persons with uncontrolled blood pressure, persons whom have
- •shown hypersensitivity to the drug or its components, in persons with eclampsia
- •or pre-eclampsia, severe coronary or myocardial disease, or a cerebrovasculair
- •accident or cerebral trauma, and in patients who use medication that ketamine
- •interacts with on a major level, such as monoamine oxidase inhibitors (MAOi).
- •- Inability to comply with treatments and/or assessments.
研究者
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