Depressive Symptoms Mild to Moderate in SeverityEarly Phase 1Keta-CareNCT06665568
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients
A Early Phase 1 study testing Intranasal ketamine hydrochloride in people with Depressive Symptoms Mild to Moderate in Severity and Anxiety, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms Mild to Moderate in Severity, Anxiety, Quality of Life (QOL)
- What is being tested?
- Intranasal ketamine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Informed Consent as documented by signature;
- Age 18 years or older;
- Able to attend study visits;
- Ability to speak and understand German.
Who cannot join
- 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);
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- 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).
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Caroline Hertler, MD, PhD, +41 44 255 13 35., caroline.hertler@usz.ch
About this study
Official title: Keta-Care - Antidepressant and Anxiolytic Effects of Intranasal Ketamine Self-administration in Palliative Care Cancer Patients: an Open-label Feasibility Study
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.
Read more
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.
Read the detailed description
With progression of cancer, patients, but also their caregivers, are predisposed to experience challenging emotional distress due to their terminal illness, resulting in depression and anxiety. However, the overall limited survival time and often complex medication regimes complicate a timely and tolerable treatment of these symptoms, when time-consuming psychotherapeutic sessions or classic antidepressant medication with side effects are unfavorable.
Ketamine is an effective and fast acting antidepressant originating from pain treatment, which can be administered non-invasively as easy to handle nasal spray. The possibility of using ketamine as needed, and not necessarily daily as classical antidepressants, limits the occurrence of side effects and has the potential to ease symptom burden in patients as well as caregivers in this vulnerable cohort. Yet, the efficacy and feasibility of intranasal ketamine self-administration in palliative care cancer patients has not been investigated to date.
In the open-label feasibility study proposed here, we aim at assessing the safety, feasibility and efficacy for the treatment of depression and anxiety with low-dose (5 mg per stroke) intranasal ketamine in a population of early palliative care cancer patients in an out-patient setting.
If self-administered nasal ketamine proves efficient and safe in this study population of often neglected palliative care patients, an easy to handle, low-cost and fast-acting drug with lower risk for interactions would be available to ease burden and emotional symptom load, and eventually increase quality of life for patients and caregivers.
- Conditions
- Depressive Symptoms Mild to Moderate in Severity, Anxiety, Quality of Life (QOL), Caregiver Burden, Sleep Quality
- Being tested
- Intranasal ketamine hydrochloride
- Keywords
- Ketamine, Caregiver burden, Open-label, feasibility, Anxiety, Depression, Palliative Care, Intranasal
- Medical subject headings
- Anxiety Disorders, Caregiver Burden, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal ketamine hydrochlorideDrug
Flexible-dose intranasal ketamine hydrochloride (5 - 50 mg)
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Other | Open-label, flexibly-dosed intranasal ketamine hydrochloride Receives: Drug: Intranasal ketamine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms assessed by the MADRS
Montgomery- Asberg Depression Scale (MADRS), 10 items, higher values indicate increasing symptom burden and total scores range from 0 to 60.
Measured: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Secondary outcomes (7)
Change in anxiety assessed by the HAM-A questionnaire
Hamilton Anxiety Rating Scale (HAM-A), 14 items, higher values indicate increasing symptom burden and total scores range from 0 to 56.
Measured: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in quality of life assessed by the QLQ-C30 questionnaire
EORTC Quality of Life Questionnaire (QLQ-C30), 30 items, higher values of questions 1-28 indicate increasing symptom burden / decreasing quality of life and total scores range from 0 to 112. Higher values on the questionnaires final two questions (29, 30) indicate improved health and quality of life. Total scores on these final two questions range from 0 to 14.
Measured: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in sleep quality assessed by the PSQI questionnaire
Pittsburgh Sleep Quality Index (PSQI), 10 items, higher values indicate decreasing sleep quality and total scores range from 0 to 21.
Measured: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Change in depressive symptoms assessed by the HADS questionnaire
Hospital Anxiety and Depression Scale (HADS), 14 items, higher values indicate increasing symptom burden and total scores range from 0 to 21.
Measured: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in caregiver burden assessed by the ZBS questionnaire (caregivers)
Zarit Burden Scale (ZBS), 22 items, higher values indicate increasing caregiver burden and scores range from 0 to 88.
Measured: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in caregiver quality of life assessed by the CarGoQoL questionnaire (caregivers)
The CareGiver Oncology Quality of Life Questionnaire (CarGoQoL), 29 items, higher values indicate increasing caregiver quality of life and total scores range from 0 to 100.
Measured: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Change in sleep quality assessed by the PSQI questionnaire (caregivers)
Pittsburgh Sleep Quality Index (PSQI), 10 items, higher values indicate decreasing sleep quality and total scores range from 0 to 21.
Measured: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Symptoms Mild to Moderate in SeverityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665568
- Sponsor's protocol ID
- Keta-Care
- Other IDs
- KLS-5644-08-2022
- Acronym
- Keta-Care
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not required to provide information about plans to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keta-Care - Antidepressant and Anxiolytic Effects of Intranasal Ketamine Self-administration in Palliative Care Cancer Patients: an Open-label Feasibility Study
- ClinicalTrials.gov ID
- NCT06665568
- Acronym / sponsor ID
- Keta-Care / Keta-Care
- Conditions
- Depressive Symptoms Mild to Moderate in Severity, Anxiety, Quality of Life (QOL), Caregiver Burden, Sleep Quality
- Keywords
- Ketamine, Caregiver burden, Open-label, feasibility, Anxiety, Depression, Palliative Care, Intranasal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With progression of cancer, patients, but also their caregivers, are predisposed to experience challenging emotional distress due to their terminal illness, resulting in depression and anxiety. However, the overall limited survival time and often complex medication regimes complicate a timely and tolerable treatment of these symptoms, when time-consuming psychotherapeutic sessions or classic antidepressant medication with side effects are unfavorable.
Ketamine is an effective and fast acting antidepressant originating from pain treatment, which can be administered non-invasively as easy to handle nasal spray. The possibility of using ketamine as needed, and not necessarily daily as classical antidepressants, limits the occurrence of side effects and has the potential to ease symptom burden in patients as well as caregivers in this vulnerable cohort. Yet, the efficacy and feasibility of intranasal ketamine self-administration in palliative care cancer patients has not been investigated to date.
In the open-label feasibility study proposed here, we aim at assessing the safety, feasibility and efficacy for the treatment of depression and anxiety with low-dose (5 mg per stroke) intranasal ketamine in a population of early palliative care cancer patients in an out-patient setting.
If self-administered nasal ketamine proves efficient and safe in this study population of often neglected palliative care patients, an easy to handle, low-cost and fast-acting drug with lower risk for interactions would be available to ease burden and emotional symptom load, and eventually increase quality of life for patients and caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Other | Drug: Intranasal ketamine hydrochlorideOpen-label, flexibly-dosed intranasal ketamine hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (16 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal ketamine hydrochlorideFlexible-dose intranasal ketamine hydrochloride (5 - 50 mg) | Drug | Ketamine |
Primary outcome
Change in depressive symptoms assessed by the MADRS
Time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Montgomery- Asberg Depression Scale (MADRS), 10 items, higher values indicate increasing symptom burden and total scores range from 0 to 60.
7 secondary outcomes
Change in anxiety assessed by the HAM-A questionnaire
Time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in quality of life assessed by the QLQ-C30 questionnaire
Time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in sleep quality assessed by the PSQI questionnaire
Time frame: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Change in depressive symptoms assessed by the HADS questionnaire
Time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in caregiver burden assessed by the ZBS questionnaire (caregivers)
Time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
Change in caregiver quality of life assessed by the CarGoQoL questionnaire (caregivers)
Time frame: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Change in sleep quality assessed by the PSQI questionnaire (caregivers)
Time frame: From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No. We are not required to provide information about plans to share individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intranasal ketamine hydrochloride in people with Depressive Symptoms Mild to Moderate in Severity and Anxiety, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Hertler, MD, PhD (+41 43 253 95 59, caroline.hertler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms assessed by the MADRS (time frame: From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.