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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Hubertus
Himmerich
+44 207 848 0187
hubertus.himmerich@kcl.ac.uk
Dr
Johanna
Keeler
+44 207 848 0071
eden@kcl.ac.uk
Treatment of depressive symptoms in people with anorexia nervosa (duration of at least 3 years) and comorbid severe depression that has not responded to at least one treatment.
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Cardiovascular conditions, including stroke, myocardial infarction or clinically significant arrythmia within 1 year of screening, uncontrolled hypertension, bradycardia, abnormalities on ECG (e.g., elongated QT interval corrected by Fridericia), based on an assessment of medical history and ECG and vital signs at screening.2. Clinically significant abnormalities in laboratory tests at screening, including full blood count, total bilirubin, creatinine, glomerular filtration rate (GFR), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). 3. Any other clinically significant physical illness or contraindication (e.g. but not limited to, renal, hepatic, pulmonary, cardiovascular, gastrointestinal) that the investigator deems may interrupt the participation in the study or pose a health risk for the participant if they were to take part in the study. 4. Relevant neurological comorbidity, in particular dementia; lifetime seizures; epilepsy; increased intracranial pressure. 5. Recent heart or head surgery. 6. Significant weight loss (≥2kg) in the month before screening.7. Weight loss of over 1kg per week between screening and baseline.8. (For females of childbearing potential) Unwillingness to follow the contraceptive requirements of the study, and to take pregnancy tests throughout the study.9. (For females) Current breastfeeding. 10. Recent illicit drug use as determined by urine drug screening at the screening visit. 11. Hypersensitivity to the study drug (KET-IR or placebo) or any of its excipients 12. Dosage in any investigational drug or device study within three months of screening or any other study that may constitute a contraindication for taking ketamine. 13. Blood or needle phobia. 14. No email access. 15. Previous or current alcohol or substance use disorder as assessed by medical history, the MINI, ASSIST and urine toxicology at screening. 16. Previous or current psychotic disorder or bipolar disorder, as assessed by a review of medical history and the MINI. 17. Previous or current schizoid, schizotypal, paranoid, histrionic, antisocial or narcissistic personality disorder, as based on medical history, the Standardised Assessment of Personality (SAPAS), the Personality Assessment Questionnaire for DSM-11 (PSQ-11) and clinical judgment 18. Current panic disorder or panic attacks/episodes within the past year, as determined by the MINI and clinical judgment 19. Significant suicide risk at screening, as assessed by suicidal behaviours during the previous year as assessed through clinical interview and medical records; suicidal ideation or significant suicidal risk expressed in the C-SSRS or during clinical interview. 20. Self-reported exposure to ketamine therapeutically or recreationally within the past six months. 21. Use of contraindicated medications as listed in the protocol.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Johanna
Keeler
+44 207 848 0071
eden@kcl.ac.uk
Dr
Hubertus
Himmerich
+44 207 848 0187
hubertus.himmerich@kcl.ac.uk
The study is sponsored by King's College London; South London and Maudsley NHS Foundation Trust and funded by Medical Research Council.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 67666
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
