Ketamine for the treatment of depression with anorexia nervosa

This randomised, double-blind, placebo-controlled Phase II trial (n=60) will study the feasibility, safety, and acceptability of oral ketamine (60–180mg, administered twice weekly) as a treatment for adults with long-standing anorexia nervosa and comorbid treatment-resistant depression.

Run by King’s College London and funded by the UK’s Medical Research Council, this study—called the EDEN project—aims to explore whether ketamine can improve depressive symptoms and recovery motivation in individuals with severe, enduring anorexia.

Participants must be aged 18 or older, have had anorexia nervosa for at least three years, and be currently experiencing depression that has not improved with at least one standard treatment. Over a six-month period, participants will attend 13 sessions, including eight in-person dosing sessions where they will receive either ketamine (using the KET-IR immediate-release capsule) or placebo in doses increasing from 60mg to a maximum of 180mg, based on tolerability. Outcomes will assess feasibility metrics (such as recruitment and retention), side effects, and exploratory changes in mood, eating disorder symptoms, and quality of life. The trial begins recruiting in August 2025 and will continue through April 2027.

Trial Details

Anorexia nervosa is a serious eating disorder that can lead to dangerously low body weight and has one of the highest death rates of any mental health condition. Around one in three people with anorexia develop a long-lasting form of the illness, often alongside depression. Unfortunately, traditional antidepressants don’t work well for people with both anorexia and depression. This study, called the EDEN project, is exploring whether a medication called ketamine—already used in the UK to treat depression—might help people with both conditions feel better and regain the motivation to recover.

Trial Number ISRCTN26462355

Data attribution

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