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

NCT06665568 | Not Yet Recruiting Early Phase 1 DMC

• 2 other identifiers: Keta-CareKLS-5644-08-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in anxiety assessed by the HAM-A questionnaire

  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

  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

  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

  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)

  From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks

Study Arms (1)

Ketamine

OTHER

Open-label, flexibly-dosed intranasal ketamine hydrochloride

Drug: Intranasal ketamine hydrochloride

Interventions

Intranasal ketamine hydrochloride DRUG

Flexible-dose intranasal ketamine hydrochloride (5 - 50 mg)

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders; Caregiver Burden; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Caroline Hertler, MD, PhD

CONTACT

+41 43 253 95 59; caroline.hertler@usz.ch

David Blum, MD, PhD

CONTACT

+41 79 154 87 47; david.blum@usz.ch

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)