Back to the list

EDEN: Ketamine for the treatment of DEpression with anorexia Nervosa

Overview

About the study
Ketamine is a drug that is commonly used as an anaesthetic in adults and children. Research has also shown that in low doses, ketamine can also have fast-acting antidepressant effects. We are currently recruiting volunteers to take part in the upcoming EDEN study, which will compare the effects of orally-delivered ketamine and a dummy pill (placebo) in 60 participants who have both anorexia nervosa and severe depression. The main aims are to explore outcomes such as how many people take part and remain in the study and how people experience both the medication and taking part in the study. However, we will also measure changes in symptoms over time.
What will it involve?
The EDEN study will take place at King’s College London (Denmark Hill campus), and you will be required to attend 10 in-person sessions and 3 online sessions. These details of these sessions are listed below:
  • Session 1: In-person screening session to determine whether you are eligible to take part in the study.
  • Session 2: Online session where will complete a series of questionnaires relating to your mental health symptoms and some computer-based cognitive tasks.
  • Sessions 3–10: In-person dosing sessions, which will take place at the testing centre. Each session will take between 3 and 4 hours. The medication we are testing is an oral version of low-dose ketamine (60–180 mg), which comes as a capsule and is swallowed. You will receive either ketamine or a dummy ‘placebo’ pill, which will be decided by random selection.
  • Session 11: In-person follow-up visit at the testing centre, where you will complete questionnaires, cognitive tasks and will have your weight measured and blood taken.
  • Sessions 12 and 13: Online follow-ups involving the completion of questionnaires and cognitive tasks.


Are you interested in taking part in this study?
Fill out this form

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.
Global Banner