A pilot study on oral s-ketamine for depression... — Clinical Trial Details

This single-site, open-label pilot evaluates feasibility and preliminary efficacy of oral S‑ketamine (Ketanest‑S) in adults with advanced, non-curable cancer and major depressive disorder and/or demoralization.

Primary outcome is feasibility judged by safety, tolerability and acceptability (eg >80% of significant adverse effects resolve within 120 minutes, <20% dropout due to adverse effects, and participant feedback). Secondary outcomes include changes in depression (BDI/HDRS), anxiety (HADS, DADDS), quality of life (MQOL) and qualitative interviews of patient experience.

Male or female; older than 18 years of age; good understanding of spoken and written Dutch; DSM-5 diagnosis of major depressive disorder (first or recurrent episode) ascertained by the MINI-plus and/or demoralization indicated by a score ≥30 on the Demoralization Scale; advanced malignancy with no curative antitumour treatment options as determined by an oncology physician.

Depression with psychotic features; previous or comorbid schizophrenia-spectrum or other psychotic disorder (excluding previous MDD with psychotic features); comorbid moderate or severe alcohol or drug dependence (excluding tobacco and caffeine); comorbid delirium; recent (within 4 weeks) or current use of non-prescribed psychoactive compounds including cannabis and St John’s wort; scheduled ECT sessions or planned changes to antidepressant treatment during the study; current use of benzodiazepines or benzodiazepine-like agents in excess of 2 mg lorazepam (or equivalent) per day; current use of ketamine; mental incompetence to provide informed consent; patients with seizures; any contraindication for ketamine use (eg uncontrolled blood pressure, hypersensitivity to ketamine or components, eclampsia/pre-eclampsia, severe coronary or myocardial disease, cerebrovascular accident or cerebral trauma, or interacting medications such as MAO inhibitors); inability to comply with treatments and/or assessments.

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

Detailed Description

Study Protocol

Preparation

Dosing

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Integration

Therapeutic Protocol

Study Arms & Interventions

Oral S-ketamine

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details