Impact of Ketamine on Depression and Anxiety in Palliative Care Patients
Résumé de l'étude
Cancer patients are often emotionally burdened during the course of the disease, leading to depression and anxiety disorders. The limited life expectancy and complex medication regimens complicate timely and tolerable treatment of these symptoms. Palliative care aims to alleviate the distressing symptoms of both patients and their caregivers at an early stage of the disease, in a patient-centered approach and alongside standard treatment. Ketamine is a medication primarily used for anesthetic purposes in emergency medicine, but is increasingly being used as an antidepressant, as ketamine acts quickly and effectively against depression. Ketamine is available as a nasal spray. Using ketamine as needed and not daily like classic antidepressants limits the occurrence of interactions with other medications and thus side effects. However, the efficacy and feasibility of intranasal self-administration of ketamine in palliative patients have not yet been studied. The aim of this study is to evaluate the safety, feasibility, and efficacy of treating depression and anxiety disorders with intranasal ketamine in oncological patients in early palliative care and its impact on the quality of life of patients and caregivers.
(BASEC)
Intervention étudiée
Our aim is to investigate the efficacy and feasibility of self-administration of ketamine as a nasal spray on depression and anxiety disorders in palliative patients.
(BASEC)
Maladie en cours d'investigation
Depression, anxiety disorders
(BASEC)
1. Age >= 18 years; 2. Progressive cancer diagnosis (life expectancy <= 24 months); 3. Clinical visit possible. (BASEC)
Critères d'exclusion
1. Cognitive impairment; 2. Alcohol and drug dependence; 3. Pregnancy. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Caroline Hertler
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Caroline Hertler
+41 43 253 95 59
caroline.hertler@clutterusz.chUniversity Hospital Zurich Department of Radiation-Oncology Competence Center Palliative Care Rämistrasse 100 CH-8091 Zurich Switzerland
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
04.02.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06665568 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Keta-Care - Antidepressant and anxiolytic effects of intranasal ketamine self-administration in palliative care cancer patients: an open-label feasibility study (BASEC)
Titre académique
Keta-Care - Antidepressant and Anxiolytic Effects of Intranasal Ketamine Self-administration in Palliative Care Cancer Patients: an Open-label Feasibility Study (ICTRP)
Titre public
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients (ICTRP)
Maladie en cours d'investigation
Depressive Symptoms Mild to Moderate in SeverityAnxietyQuality of Life (QOL)Caregiver BurdenSleep Quality (ICTRP)
Intervention étudiée
Drug: Intranasal ketamine hydrochloride (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Change in depressive symptoms assessed by the MADRS (ICTRP)
Change in anxiety assessed by the HAM-A questionnaire;Change in quality of life assessed by the QLQ-C30 questionnaire;Change in sleep quality assessed by the PSQI questionnaire;Change in depressive symptoms assessed by the HADS questionnaire;Change in caregiver burden assessed by the ZBS questionnaire (caregivers);Change in caregiver quality of life assessed by the CarGoQoL questionnaire (caregivers);Change in sleep quality assessed by the PSQI questionnaire (caregivers) (ICTRP)
Date d'enregistrement
29.10.2024 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Caroline Hertler, MD, PhDCaroline Hertler, MD, PhD, caroline.hertler@usz.chcaroline.hertler@usz.ch, +41 43 253 95 59+41 44 255 13 35. (ICTRP)
ID secondaires
KLS-5644-08-2022, Keta-Care (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06665568 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible