King’s researchers have been awarded the funds the MRC Developmental Pathway Funding Scheme to run a randomised controlled feasibility trial of oral ketamine vs placebo in people with both anorexia nervosa and treatment resistant depression, marking the first time that ketamine has been used in a trial of this kind.
Approximately a third of people diagnosed with anorexia nervosa go on to develop a persisting form of the illness, which is frequently accompanied by depression, which is a barrier to recovery. Existing anti-depressant medications prove generally ineffective in treating depression in patients with anorexia and new treatment options are necessary. The EDEN (kEtamine for DEpression with anorexia Nervosa). Project will explore ketamine as possible treatment route for people with these conditions.
Ketamine is currently used for the treatment of depression in the UK and may be effective in patients with anorexia nervosa and additional depression. The hope for this study is that people with both anorexia and depression will experience relief from depression, which will help them to find hope and improve their ability to engage in psychotherapy and to work towards recovery and a better quality of life.
The EDEN project aims to investigate the effect of ketamine in alleviating depression in 60 adults with a diagnosis of persisting anorexia and treatment-resistant depression. Participants in the study will randomly receive either ketamine, or a placebo, twice a week across a period of six months. To verify that the drug is tolerable, the first four doses will be given in the Clinical Research Facility at King’s College London, where participants will be monitored by medical professionals. After this point, and if the drug is tolerated well, it is intended that participants will be able to take the drug home.
Measurements of depression, anorexia symptoms, suicidality, and quality of life will be taken after 28 days, and at three, six and seven months. This is a preliminary study, looking at feasibility of the study, and of the drug, examining recruitment rate, retention of people within the study and the tolerability of the drug. The study will use qualitative data collection, in the form of semi-structured interviews, with both participants and their carers to explore the experience of the trial and help design and optimise future studies. Blood samples will also be taken to look assess levels of ketamine and brain-derived neurotrophic factor (BDNF), which is a molecule involved in the growth and survival of brain cells.
The EDEN Project is led by Dr Hubertus Himmerich with Dr Johanna Keeler, Professor Janet Treasure, Professor Allan Young, Professor Mitul Mehta, Dr Mario Juruena, Dr Carol Kan and Dr Ben Carter.