Clinical TrialPalliative & End-of-Life DistressKetamineNot yet recruiting

Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients (Keta-Care)

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.

Target Enrollment
100 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

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.

Study Arms & Interventions

Intranasal ketamine

experimental

Open-label, flexible-dose intranasal ketamine self-administration

Interventions

  • Ketamine5 - 50 mg
    via Other• as needed over 8 weeks

    Flexible-dose intranasal ketamine (5–50 mg) self-administered; registry lists 5–50 mg range.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria (patients):
  • Informed Consent as documented by signature;
  • HADS total score of 6 or greater;
  • Age 18 years or older;
  • Progressive cancer diagnosis (estimated life expectancy 24 months or more)
  • Able to attend study visits;
  • Ability to speak and understand German;
  • Exclusion Criteria (patients):
  • Clinician assessed cognitive impairment;
  • Clinician assessed alcohol or drug abuse;
  • Pregnancy or breast-feeding;
  • Severe hypertension (greater than 200/120 mmHg);
  • Anamnestic mood disorder (major depressive disorder, treatment resistant depression, etc.);
  • Suicidality (C-SSRS total score of "low" or less);
  • Weight less than 39 kg, greater than 170 kg;
  • Angina pectoris or myocardial infarction in the last 6 months;
  • Lifetime abuse or dependence on ketamine or phencyclidine;
  • Substance abuse or dependence in the 6 months before screen;
  • Nasal obstructions or history of nasal surgery.
  • Serious health risk caused by increased blood pressure or intracranial pressure:
  • Known aneurysmal vascular disease (including intracranial, thoracic or abdominal aortic or peripheral arterial vessels);
  • Known history of intracerebral hemorrhage;
  • Recent (within 6 weeks) cardiovascular event including myocardial infarction (MI).
  • Inclusion criteria (caregivers):
  • Informed Consent as documented by signature;
  • Age 18 years or older;
  • Able to attend study visits;
  • Ability to speak and understand German.
  • Exclusion criteria (caregivers):
  • None.

Exclusion Criteria

  • See inclusionCriteria field above (includes both patient and caregiver exclusions).

Study Details

Locations

University Hospital Zurich — Zurich, Canton of Zurich, Switzerland

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