AuthorisedTherapeutic exploratory (Phase II)Interventional

The therapeutic potential of psilocybin in anorexia nervosa in young adults

This research is looking into a new way to help young adults who have anorexia nervosa. It's testing a substance called psilocybin to see if it's safe and if it could help improve the condition. The main focus is to carefully track any side effects that might happen during the study. Researchers will also be checking how participants' anxiety levels change, their general mood, and how satisfied they feel with their lives overall. They want to understand if this treatment could lead to people feeling better and having fewer symptoms of anorexia nervosa. All results will be carefully monitored.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Skane

Enrolment target

Start

18 Jun 2025

Anorexia Nervosa

What is this study about?

This study is exploring whether a substance called psilocybin could be a new way to help young adults who have anorexia nervosa. Anorexia nervosa is a serious eating disorder where people intensely fear gaining weight and have a distorted body image. Finding effective treatments for this condition is very important.

In this particular study, the main goal is to carefully watch for any side effects that might happen when people take psilocybin. This is a crucial step in understanding if a potential new treatment is safe. The researchers will be looking at both common side effects and any more serious reactions. This study is in an early stage (Phase II), which means it's testing a new idea and making sure it's safe before moving on to larger studies.

Beyond safety, the study also wants to see if psilocybin might help with some of the difficult feelings and symptoms linked to anorexia nervosa. They will be asking participants about their anxiety, their general mood, how they feel about their relationships, and their overall satisfaction with life. They will also track changes in eating disorder symptoms and whether participants show signs of getting better or recovering. This will help them understand if psilocybin could offer real hope for people with anorexia nervosa.

Key takeaways

This study explores psilocybin for anorexia nervosa in young adults.
The main focus is to ensure the treatment is safe by closely tracking side effects.
It also checks if psilocybin helps with anxiety, mood, and life satisfaction.
Participants must be 18 years or older, with no upper age limit.
It's a Phase II study, meaning it's an early step in testing a new treatment.

Who may be eligible?

This study is looking for young adults aged 18 and older. There is no upper age limit, so people of many different ages can take part as long as they are at least 18.

They are open to both men and women joining the study. If you have anorexia nervosa and are at least 18, you might be able to participate. Specific health checks will be done to make sure it's safe for you to take part.

Quick self-check

Are you 18 years old or older?
Do you have anorexia nervosa?
Are you willing to discuss your health and medical history with the study team?
Are you open to potentially trying a new, experimental treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would likely have several visits to the research clinic. These visits would involve taking the study medication (psilocybin) under close medical supervision. You would also complete various questionnaires and assessments to track your feelings, mood, and any changes in your anorexia nervosa symptoms. Researchers would carefully monitor you for any side effects. After the main treatment period, there would be follow-up appointments over about six months to see how you are doing long-term. The total duration of your involvement could be several months.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new approach to treating anorexia nervosa that isn't widely available yet, which could potentially improve your symptoms and well-being. However, there are also potential risks, as psilocybin can cause psychological effects and other side effects, which will be carefully monitored. You will be fully informed about all known risks before deciding to join, and you always have the right to withdraw from the study at any time without giving a reason.

Locations (1)

—
Sweden

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain mushrooms that can affect your mood, thoughts, and senses. It's being studied for its potential medical uses.

What does 'Phase II study' mean?

It means this is an early study to see if a new treatment is safe and if it works for the condition. It's often followed by larger studies if the results are positive.

Will I have to stay at the clinic?

The information provided doesn't specify an overnight stay, but you would be closely monitored for several hours after taking the study medication.

What kind of side effects are they looking for?

Researchers will be looking for any unwanted effects, both mild and serious, that might happen while you are taking part in the study.

Can I still get my usual treatment for anorexia nervosa?

This would be an important question to ask the study team, as it depends on the specific design of the trial.