RecruitingPhase IIInterventional

Ketamine for the treatment of depression with anorexia nervosa

This study, called the EDEN project, is exploring if a medicine called ketamine can help people who have lived with anorexia nervosa for at least three years and also suffer from severe depression that hasn't responded to other treatments. Anorexia is a serious eating disorder, and depression often makes it harder to recover. While traditional antidepressants often don't work for this combination of conditions, ketamine is already used for depression in the UK. This trial will test a new form of ketamine or a dummy pill to see if it can improve depression, boost motivation, and help people on their journey to recovery. Participants will attend a series of in-person and online sessions over about six months.

At a glance

Status

Recruiting

Phase

Phase II

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Oct 2027

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.

What is this study about?

Anorexia nervosa is a very serious eating disorder that can make people dangerously underweight and has a significant impact on health. Many people who have lived with anorexia for a long time also experience severe depression, which can make it even harder to get better. Unfortunately, the usual antidepressant medicines often don't help much when someone has both anorexia and depression.

This is why researchers are running the EDEN study. They want to see if a medication called ketamine, which is already used to treat depression in the UK, could be a new way to help. The idea is that if ketamine can lift depression, it might also give people more hope and motivation to work towards recovery from their anorexia.

This study hopes to find out if ketamine can improve the depressive symptoms in people with long-term anorexia, potentially opening up new treatment options for a condition that is currently very difficult to treat effectively. It's an important step towards finding better ways to support people facing these challenges.

Key takeaways

The study is for people with long-term anorexia nervosa and severe depression.
It aims to see if ketamine can improve depression and motivation for recovery.
Participation involves 13 sessions (in-person and online) over about 6 months.
You might receive ketamine or a dummy pill (placebo).
There's a chance it could help your depression, but no guarantee.
The study has specific health requirements and checks to ensure safety.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have been diagnosed with anorexia nervosa for at least three years. It's also important that you are currently experiencing severe depression, which hasn't improved even after trying at least one other treatment.

There are also some physical health checks: you need to weigh at least 40kg and have a Body Mass Index (BMI) of 14 or higher. The team will also check your general health, blood tests, and heart to make sure it's safe for you to take part. You must also be registered with a GP in the UK.

However, you won't be able to join if you've recently had heart problems like a stroke or heart attack, or have other serious health issues like uncontrolled high blood pressure or significant kidney or liver problems. The research team will review your medical history carefully to make sure the study is right and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or over?
Have you had anorexia nervosa for at least 3 years?
Are you currently experiencing severe depression not helped by other treatments?
Do you weigh at least 40kg and have a BMI of 14 or higher?
Are you willing and able to attend study appointments in London?
Do you have a GP in the UK that the study team can contact?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about six months and involve 13 sessions. First, you'll have an in-person screening visit to check if you're suitable. Then, there's an online session with some questionnaires and computer tasks.

The main part involves 8 in-person sessions where you will randomly receive either the study medication (ketamine) or a non-active dummy pill (placebo). No one, not even you or the study staff, will know which one you are taking. These sessions will be in the morning and last about 3 to 4 hours each. After these, you'll have one more in-person session for questionnaires, tasks, and a blood test, followed by two more online follow-up sessions with questionnaires and tasks.

Throughout the study, the team will closely monitor your health and well-being to ensure your safety.

Potential risks and benefits

The main potential benefit of joining this study is that your depression might improve, which could then help you feel more motivated and hopeful about recovering from anorexia. However, as with any research study, there's no guarantee that you will personally benefit. It's also important to be aware that ketamine can have side effects, and some people might find the appointments and tests challenging or time-consuming. You can choose to leave the study at any time without giving a reason, and your regular medical care will not be affected. The study team will monitor your health very closely throughout your participation.

Locations (1)

King's College London
Approximate
London, United Kingdom

Common questions

What is anorexia nervosa?

Anorexia nervosa is a serious eating disorder where people try to keep their weight as low as possible, often by restricting food, which can lead to severe health problems.

What is ketamine?

Ketamine is a medication that is used as an anaesthetic and, in lower doses, is also approved in the UK for treating severe depression.

What does 'placebo' mean?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredient. It's used in studies to compare the effects of the active medicine.

Will I know if I'm getting ketamine or a placebo?

No, you won't. This is called 'blinding,' and it helps ensure the study results are fair and accurate. Neither you nor the study team will know until the study is over.

Where is the study taking place?

This study is being run from King's College London in the UK.

How to find out more

Johanna Keeler

eden@kcl.ac.uk +44 207 848 0071 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.