A pilot study on oral s-ketamine for depression and demoralization in patients with advanced cancer receiving palliative care
Open-label Phase II pilot (n=10) assessing feasibility of oral S-ketamine (Ketanest-S) to treat depression and demoralization in patients with advanced cancer receiving palliative care.
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.