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EDEN: Ketamine for the treatment of DEpression with anorexia Nervosa

Overview

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.
 
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Planned end date

02 Feb 2028 23:55

Conditions

Anorexia,Depression

Inclusion Criteria

Inclusion criteria will include:
  1. 1. Signed informed consent form
  2. SE-AN as defined by i) a primary diagnosis of AN as specified in the International Classification of Diseases (ICD)-11 and ii) at least 3 years history of AN (since diagnosis), based on medical records, clinical assessment, BMI, MINI at screening
  3. Severe depression with a failed treatment attempt, as defined by i) severe depression as specified in the ICD-11 and ii) non-response or failure to achieve remission after one or more treatments recommended by NICE for severe depression.
  4. Aged 18 years old or above at screening
  5. Capacity to consent
  6. Screening Body Mass Index (BMI) > = 14kg/m2
  7. Weight above 40kg
  8. At low risk for suicidality as assessed by the research team
  9. Medically stable as determined by screening: clinical interview, clinical laboratory values, vital signs, ECG and medical history.
  10. Agreement to follow the contraception requirements of the study.
  11. Registered with a General Practitioner (GP) in the UK, and agreement for the team to maintain contact with the GP and/or specialist ED team for the duration of the study.

Additional inclusion criteria for optional digital diary component:

12. Have daily access to an iPhone or a smartphone running the Android system.

Exclusion Criteria

Exclusion relating to potentially confounding or contraindicated diseases and therapies:
  1. Prior or ongoing alcohol or substance use disorder as assessed by medical history, the MINI, ASSIST and urine toxicology at screening.
  2. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder or brief psychotic disorder (unless substance induced or due to a medical condition) as assessed by medical history and the MINI.
  3. Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic or antisocial personality disorder based on medical history, the Standardised Assessment of Personality (SAPAS), the Personality Assessment Questionnaire for DSM-11 (PSQ-11) and clinical judgment
  4. Current panic disorder or panic attacks/episodes within the past year, as determined by the MINI and clinical judgment
  5. Significant suicide risk as defined by (1) suicidal ideation as endorsed on the C-SSRS, or during clinical interview at screening; (2) suicidal behaviours within the past year as assessed during clinical interview or by medical records; (3) clinical assessment of significant suicidal risk during clinical interview at screening.
  6. Exposure to ketamine therapeutically or recreationally within the past six months.
  7. Use of medications listed as a contraindication in the Investigator's Brochure and protocol section 5.3.2.
General exclusion criteria:
  1. Significant weight loss (> 1kg per week) between screening and baseline.
  2. Rapid weight loss (> = 2kg) in the previous month.
  3. Cardiovascular conditions: recent stroke (< 1 year prior to signing of ICF), recent myocardial infarction (< 1 year prior to signing of ICF), uncontrolled hypertension (blood pressure > 140/90 mmHg), bradycardia (< 50 beats per minute [bpm]), elongated QT interval corrected by Fridericia (QTcF; > 450 ms for men and > 470 ms for women), or clinically significant arrhythmia (< 1 year prior to signing the ICF) based on vital signs and ECG measurement at screening and baseline and medical history.
  4. Clinically significant laboratory test abnormalities at screening and baseline including full blood count (haemoglobin < 10 g/dL), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > = 3 × upper limit of normal (ULN), total bilirubin > = 1.5 × ULN or alkaline phosphatase > = 2.5 × ULN, reduced glomerular filtration rate (GFR< 60) or creatinine > 1.5 × ULN.
  5. A female who is currently breastfeeding, is unwilling to take a pregnancy test or is unwilling to take effective contraceptive measures as specified under section 5.2.2. on study restrictions. No willingness to take pregnancy test (females).
  6. Positive urine drug screen for illicit drugs or drugs of abuse at screening and/or baseline. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator’s discretion in conjunction with the medical monitor.
  7. Relevant neurological comorbidity, in particular dementia; lifetime seizures; epilepsy; increased intracranial pressure.
  8. Recent heart or head surgery.
  9. Dosage in any investigational drug or device study within three months of screening.
  10. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.
  11. Hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
  12. Blood or needle phobia.
  13. No email access.
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