Ketamine for the treatment of DEpression with anorexia Nervosa

  • Research type

    Research Study

  • Full title

    Ketamine for the treatment of DEpression with anorexia Nervosa: A randomised controlled feasibility study to test recruitment, treatment acceptance, adherence, safety, and outcome measures assessment (EDEN)

  • IRAS ID

    340838

  • Contact name

    Hubertus Himmerich

  • Contact email

    hubertus.himmerich@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    2 years, 9 months, 0 days

  • Research summary

    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 feasibility and acceptability of a randomised-controlled design examining oral ketamine versus placebo for the alleviation of depression in 60 adults with a diagnosis of longstanding anorexia (≥3 years) and severe depression that has not responded to treatment. Participants in the study will randomly receive either ketamine, or a dummy pill, twice a week for four weeks (eight doses in total). All doses will be given in the Clinical Research Facility at King's College London, where participants will be monitored by medical professionals. 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- and 6- months, therefore the participation period for each participant is 6 months.

    The EDEN project is funded by the Medical Research Council Developmental Pathway Funding Scheme.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    25/LO/0279

  • Date of REC Opinion

    12 Jun 2025

  • REC opinion

    Further Information Favourable Opinion