Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients (NCT06665568) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients
Switzerland100 participantsStarted 2025-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in depressive symptoms assessed by the MADRS
Timeframe: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks