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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Caregiver Burden; Sleep Quality; Depressive Symptoms Mild to Moderate in Severity; Quality of Life (QOL)
• Intervention / Treatment: Drug: Intranasal ketamine hydrochloride

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Caroline Hertler, MD, PhD; Phone Number: +41 43 253 95 59; Email: caroline.hertler@usz.ch
• Study Contact Backup: Name: David Blum, MD, PhD; Phone Number: +41 79 154 87 47; Email: david.blum@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
    • Contact: Caroline Hertler, MD, PhD; Phone Number: +41 44 255 13 35.; Email: caroline.hertler@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ketamine; Open-label, flexibly-dosed intranasal ketamine hydrochloride	Drug: Intranasal ketamine hydrochloride; Flexible-dose intranasal ketamine hydrochloride (5 - 50 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Ketamine; Open-label; Caregiver burden; Palliative Care; feasibility; Intranasal
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Stress, Psychological; Caregiver Burden; Anxiety Disorders; Depression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Ketamine
• Other Study ID Numbers: Keta-Care; KLS-5644-08-2022 (Other Grant/Funding Number: Swiss Cancer League)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not required to provide information about plans to share individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No