Depression and demoralisation, advanced (non-curable) cancer
Conditions
Interventions
Oral S-ketamine, twice weekly for five weeks
Sponsors
Investigator-initiated
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
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; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Limited efficacy testing: 1.1)Decrease in depression symptom severity, expressed as a decrease in total score on the Hamilton Depression Rating Scale (HDRS17); 1.2)Decrease in demoralization severity, expressed as a decrease in total score on the DS; 2.Safety/tolerability: 2.1)Systematic Assessment for Treatment Emergent Effects (SAFTEE); 2.2)The Iowa Sleep Disturbance Inventory (ISDI); 2.3)The Dissociation Tension Scale (DSS); 2.4)Interstitial Cystitis Symptoms and Problems Index (ICSI/ICPI): 2.5)Monitoring of body weight, blood pressure and liver enzyme levels; 3.Recruitment/retention rates. | — |
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: o Hospital Anxiety and Depression Scale (HADS) anxiety subscale; o Death and Dying Distress Scale (DADDS); • Subjective experiences of participants during the trial, as assessed by in-depth, semi-structured interviews. | — |
Contacts
Public ContactNina Schimmel
University Medical Center Groningen
Outcome results
None listed