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

Investigator-initiated0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•Male or female;
•Older than 18 years of age;
•Signed informed consent;
•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 DS;
•Advanced malignancy with no curative antitumor treatment possibilities as determined by a physician at the oncology department.

•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 would constitute a serious hazard, 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.

发起方

Investigator-initiated