A pilot study on oral s-ketamine for depression and demoralization in patients with advanced cancer receiving palliative care

niversity Medical Center Groningen0 个研究点目标入组 10 人开始时间: 2020年11月22日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•Male or female;
•Older than 18 years of age;
•Good 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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;
•- In patients with seizures;
•- 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.

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