2026 ECNP Congress

PS02-2063

A randomised–controlled feasibility study of ketamine for the treatment of depression with anorexia nervosa

Johanna Keeler — H. Himmerich, J. Treasure, Y. Benbow, K. Rowlands, J. Law, R. Morris, A. Young, M. Mehta, M. Juruena, B. Carter, C. Kan, V. Lawrence · King's College London, Institute of Psychiatry- Psychology and Neuroscience, London, United Kingdom

2026 ECNP Congress

Background

Approximately a third of people with anorexia nervosa (AN) develop a severe and enduring form of the illness, which is frequently accompanied by severe depressive symptoms or a co-morbid affective disorder. This can be a key barrier to recovery and has been identified as a negative prognostic factor. Anti-depressant medications such as selective serotonin reuptake inhibitors are less effective in treating depression in patients with acute AN, thus new pharmacological treatment options are needed. Ketamine is currently used for treatment-resistant depression in the UK and may be effective in patients with both AN and depression.

Aims

The primary objective of the EDEN study is to investigate the feasibility of using oral ketamine in this population, as indicated by participant recruitment, assessment response rate and drop-out rate. Secondary objectives include acceptability of the intervention, changes in key outcomes (depression, eating disorder symptoms, and quality of life) at 28 days, 3- and 6-months post-randomisation, and to collect data on the safety and tolerability of oral ketamine in this population.

Methods

The EDEN study is a randomised, double-blinded (participant, researchers, assessors and analyst), single-centre, placebo-controlled feasibility study of 60 adults (≥18 years old) with a diagnosis of depression that has not responded to one or more treatments and AN with a duration of ≥3 years. Participants are randomised (1:1) to receive oral ketamine 60-180mg, or placebo, twice per week for four weeks. Study participation consists of three phases; (i) Pre-dose Assessments (Screening and Baseline), (ii) Dosing period (8 dosing visits, twice weekly for 4 weeks) and (iii) Follow-up (at 28 days end of intervention, 3- and 6-months post-randomisation). Clinical outcome measures include depressive symptoms, eating disorder symptoms, suicidality, quality of life, and qualitative data is collected via pre and post-participation interviews to assess acceptability of the study and treatment. Neuropsychological functioning is measured at all time-points using a broad cognitive task battery. The study is funded by the UKRI Medical Research Council Developmental Pathway Funding Scheme.

Results

Recruitment for the study commenced in August 2025. Quantitative feasibility results of the study will be available in 2028. However, individual experiences of patients taking part in the study so far will be presented.

Discussion and Conclusions

Treating depressive symptoms in individuals with AN currently remains a clinical challenge, given that typical anti-depressants show little efficacy in this population. An adequately powered future Phase II RCT comparing low-dose oral ketamine with a placebo is needed to definitively determine its effectiveness and safety in treating depression in people with AN. Given that there are challenges in recruiting and retaining this patient group for treatment RCTs, particularly where a pharmacological intervention may be involved, we hope that the results from this feasibility study will inform the development of a successful RCT protocol.

References

No references.