Not yet recruitingEarly Phase 1

Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients

NCT06665568 · Keta-Care · University of Zurich

Closed to entry

Status

Not accepting participants

Early Phase 1

Phase

100

Target enrolment

Study sites

Outside the US

What it is testing

Summary

With progression of cancer, patients and their caregivers experience challenging emotional distress, which can make them feel depressed and very anxious. Patients with advanced cancer often do not have long to live. However, most antidepressants take a long time to act and cause unwanted side effects. There is hence a need for a fast acting antidepressant with fewer unwanted side effects. Ketamine is an effective and fast acting antidepressant originating from pain treatment, which has few unwanted side effects. It can be taken by a patient as a nasal spray when it is needed. The idea of treating depression and anxiety in cancer patients in palliative care with ketamine nasal spray is new. How effective ketamine will be at reducing depression and anxiety in patients is unknown . It is also unknown whether this kind of treatment will be safe and practical for palliative care patients. This study aims to answer these questions. Patients will be treated with a low dose (5 mg) of ketamine nasal spray and then measure its effectiveness, practicality and safety. Questionnaires will be used to measure these outcomes. If treating depression and anxiety with ketamine nasal spray proves to be effective, practical and safe, then it could help to improve the quality of life for palliative care patients and reduce the burden of their caregivers.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in depressive symptoms assessed by the MADRS
Measured over From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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.

Where

1 study site

Facility	City	Region	Country
University Hospital Zurich	Zurich	Canton of Zurich	Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06665568 on ClinicalTrials.gov →

Last updated in the registry 2025-05-01. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

All 7 trials from University of Zurich →