A pilot study on oral s-ketamine for depression and demoralization in patients with advanced cancer receiving palliative care

This open-label trial (n=10) investigates the feasibility of a future randomized controlled trial (RCT) on the efficacy of oral esketamine in treating depression and demoralization in advanced cancer patients receiving palliative care.

Conducted by the University Medical Center Groningen in the Netherlands, the study aims to assess safety, tolerability, and acceptability, with primary endpoints including the resolution of adverse effects and participant feedback. Efficacy will be measured by a clinically significant reduction in depression and demoralization symptoms in at least 30% of participants. Secondary endpoints encompass changes in depression severity, anxiety levels, quality of life, and subjective experiences.

The trial involves adults (18-64 years), both male and female, with advanced malignancy and no curative treatment options. The oral S-ketamine intervention will be evaluated through in-depth interviews, the Beck Depression Inventory, McGill Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, and Death and Dying Distress Scale.

The trial, authorised on February 24, 2021, and with a favourable ethics committee opinion on September 17, 2020, is expected to conclude 12 months after the first inclusion or when the 10th participant completes the study.

Topic Depression Palliative Care
Compound Ketamine
Country Netherlands
Visit trial
Status Active, not recruiting
Results Published No
Start date 17 September 2020
End date 31 December 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 18- 64
Therapy Yes

Trial Details

This ongoing trial (n=10) by the University Medical Center Groningen assesses the feasibility of using oral S-ketamine for depression and demoralization in advanced cancer patients. The trial involves adults (18-64 years), measures safety, tolerability, and efficacy, and is expected to conclude 12 months after the first inclusion or the 10th participant completing the study.

Trial Number 2019-001621-27

Sponsors & Collaborators

University of Groningen
The University of Groningen, established in 1614, is a prestigious institution that ranks among the world's top universities. It has taken a pioneering role in the interdisciplinary research of psychedelics, harnessing its rich academic heritage and a forward-looking approach to exploring the potential of psychedelic substances in treating various mental health conditions.

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