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

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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

•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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Limited efficacy testing: <br>1.1)Decrease in depression symptom severity, expressed as a decrease in total score on the Hamilton Depression Rating Scale (HDRS17); <br>1.2)Decrease in demoralization severity, expressed as a decrease in total score on the DS;<br>2.Safety/tolerability: <br>2.1)Systematic Assessment for Treatment Emergent Effects (SAFTEE);<br>2.2)The Iowa Sleep Disturbance Inventory (ISDI);<br>2.3)The Dissociation Tension Scale (DSS);<br>2.4)Interstitial Cystitis Symptoms and Problems Index (ICSI/ICPI):<br>2.5)Monitoring of body weight, blood pressure and liver enzyme levels;<br>3.Recruitment/retention rates.<br>

Secondary Outcome Measures

Name	Time	Method
•Decrease in self-reported depression severity, as expressed by a decrease in total score on the Beck Depression Inventory (BDI);<br>•Changes in patients’ quality of life, as expressed by a decrease in total score on the McGill Quality of Life Questionnaire (MQOL); <br>•Decrease in anxiety, expressed as a decrease in total score on the: <br>oHospital Anxiety and Depression Scale (HADS) anxiety subscale;<br>oDeath and Dying Distress Scale (DADDS);<br>•Subjective experiences of participants during the trial, as assessed by in-depth, semi-structured interviews. <br>