Open-label single-group early phase I feasibility study (n=100) of flexible-dose (5–50 mg) intranasal ketamine self-administration over 8 weeks for depression and anxiety in palliative cancer patients.
Patients with progressive cancer and their caregivers commonly experience marked depression and anxiety; rapid-acting, well-tolerated treatments are needed given limited survival time and polypharmacy.
This open-label feasibility study will assess safety, feasibility and preliminary efficacy of low-to-moderate dose intranasal ketamine (flexible 5–50 mg per administration) self-administered over an 8-week outpatient period, using questionnaires for depression, anxiety, sleep quality, quality of life and caregiver burden.
Outcomes include tolerability, adverse events, and symptom change on validated scales; caregivers invited to participate in parallel assessments.
Open-label, flexible-dose intranasal ketamine self-administration
Flexible-dose intranasal ketamine (5–50 mg) self-administered; registry lists 5–50 mg range.