Impact of Ketamine on Depression and Anxiety in Palliative Care Patients
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Depression, anxiety disorders
(BASEC)
1. Age >= 18 years; 2. Progressive cancer diagnosis (life expectancy <= 24 months); 3. Clinical visit possible. (BASEC)
Criteri di esclusione
1. Cognitive impairment; 2. Alcohol and drug dependence; 3. Pregnancy. (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Caroline Hertler
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
04.02.2025
(BASEC)
ID di studio ICTRP
NCT06665568 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Keta-Care - Antidepressant and anxiolytic effects of intranasal ketamine self-administration in palliative care cancer patients: an open-label feasibility study (BASEC)
Titolo accademico
Keta-Care - Antidepressant and Anxiolytic Effects of Intranasal Ketamine Self-administration in Palliative Care Cancer Patients: an Open-label Feasibility Study (ICTRP)
Titolo pubblico
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients (ICTRP)
Malattie studiate
Depressive Symptoms Mild to Moderate in SeverityAnxietyQuality of Life (QOL)Caregiver BurdenSleep Quality (ICTRP)
Intervento studiato
Drug: Intranasal ketamine hydrochloride (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
29.10.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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 secondari
KLS-5644-08-2022, Keta-Care (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06665568 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile