ICF: kEtamine for the treatment of DEpression with anorexia Nervosa (EDEN)

Anorexia nervosa is a restrictive eating disorder that has a high rate of death. Approximately a third of people develop a persisting form of illness, which is often accompanied by depression, which is a barrier to recovery. Anti-depressant medications are not effective in treating depression in patients with chronic anorexia and new treatments are needed.
Ketamine is currently used for the treatment of depression in the UK and may be effective in patients with AN and additional depression. The hope for this study is that people with both, anorexia, and depression, will experience relief from depression and thus get back their hope for improvement, motivation, and strength to fight their anorexia.
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 dummy pill, twice a week for a total 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, participants can take the drug home. All participants will also receive ten "psychoeducation and integration" sessions which are designed to increase the beneficial effects of ketamine. The main outcome will be looking at whether a sufficient number of people were recruited into the study and did not drop out over the duration of the study period, and whether people found the drug, as well as taking part in the study itself, acceptable. Measurements of depression, anorexia symptoms, suicidality, and quality of life will be taken after 28 days, and 3-, 6- and 7 months. Blood samples will also be taken in order to look at levels of ketamine.

Anorexia nervosa (AN) has the highest mortality of any mental illness, with a SMR of 5.9 and 57-fold increased risk for suicidality. A third of people with AN develop a severe-enduring form of the illness (SE-AN), which has serious physical and psychosocial consequences. AN is highly co-morbid with depression, which contributes to a poor prognosis. The treatment options for SE-AN are limited. As anti-depressant treatment lacks efficacy, there is a real need for novel intervention to address co-morbid depression in people with SE-AN. Ketamine is already used for the treatment of treatment-resistant depression (TRD) in the UK. The proposed study is a double-blinded randomised controlled feasibility trial in 60 adults (age>18) with TRD and SE-AN.