hopelessness Sadness
Conditions
Interventions
Patients will receive an oral dose of 0.5 mg (minimum) to 3.0 mg (maximum)
S-ketamine twice per week for a five week period.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this pilot study is to decide whether it is feasible to conduct a larger trial on the effectiveness of oral esketamine for the treatment of depression and demoralization in patients with advanced cancer receiving palliative care. This will be judged by preliminary effectiveness, safety, tolerance and acceptability of the intervention, and acceptability of the study procedures. These parameters will be assessed both quantitatively and qualitatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Decrease in self-reported depression severity, as expressed by a decrease in total score on the Beck Depression Inventory (BDI); • Changes in patients* quality of life, as expressed by a decrease in total score on the McGill Quality of Life Questionnaire (MQOL); • Decrease in anxiety, expressed as a decrease in total score on the Death and Dying Distress Scale (DADDS); • Experiences of participants during the trial, as assessed by in-depth, semi-structured interviews. | — |
Countries
Netherlands
Outcome results
None listed