AuthorisedTherapeutic exploratory (Phase II)Interventional

The Danish Anorexia Nervosa Psilocybin RCT (DANP-RCT). A Randomised, Active-Placebo-Controlled, Triple-blind, Superiority Study of Psilocybin-Assisted Acceptance and Commitment Therapy (ACT) in the Treatment of Treatment-resistant Anorexia Nervosa.

Anorexia nervosa is a serious eating disorder that can be difficult to overcome, especially when standard treatments have not helped. This study looks at a new approach called psilocybin-assisted therapy. Psilocybin is a compound originally found in certain mushrooms, given here in a pure, medical form alongside a talking therapy known as Acceptance and Commitment Therapy (ACT). The trial aims to find out if this treatment is safe and helpful for adult women with long-standing anorexia. Participants are randomly chosen to receive either psilocybin or a comparison medicine, both combined with structured therapy sessions. Doctors and researchers will track each person's progress over 22 weeks, checking physical health, thoughts around food, and general wellbeing. The goal is to see if this treatment can help break rigid thought patterns and offer new hope for recovery.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Slagelse Hospital

Enrolment target

Start

01 Aug 2026

Anorexia nervosa

What is this study about?

Anorexia nervosa is a complex condition where people severely restrict their food intake, often driven by an intense fear of weight gain and unhelpful thoughts about their body shape. While standard therapies and nutritional support work well for many, some people live with the condition for years without finding lasting relief. Doctors describe this as 'treatment-resistant' anorexia. When usual care options are exhausted, scientists look for new ways to support the brain and mind.

This trial investigates a medicine called PEX010, which contains psilocybin, combined with Acceptance and Commitment Therapy (ACT). Psilocybin is thought to encourage flexibility in brain pathways, which might help people step away from persistent, rigid thoughts about food and body image. In this trial, the medicine is not taken alone; it is paired with professional psychological support to help participants process difficult feelings and build healthier coping habits.

Because this is a carefully designed study, participants are split into groups to fairly test the results. One group receives psilocybin, while the other receives an active comparison medicine, with both groups getting the full therapy programme. Neither the participants nor the research team know who receives which pill until the end. This helps researchers gather clear, trustworthy evidence on whether psilocybin-assisted therapy could become a valuable future treatment option.

Key takeaways

The trial tests psilocybin medicine combined with talking therapy for difficult-to-treat anorexia nervosa.
It is open to women aged 18 and older who have not had success with standard eating disorder treatments.
Participants take part in therapy sessions and one supervised medicine session over a 22-week period.
Half of the participants receive psilocybin, while the other half receive a comparison medicine.
Participation is entirely voluntary, and you can withdraw from the study at any time.

Who may be eligible?

This trial is designed for adult women aged 18 and older who are living with anorexia nervosa. It is specifically aimed at people whose eating disorder has not improved despite trying standard medical and psychological treatments.

Because safety is the main priority, participants will need to complete health checks before joining. These checks look at both physical health, such as heart function, and mental health history. People with certain medical conditions or specific psychiatric diagnoses may not be able to take part safely.

If you think this study might apply to you, your doctor or the study team can look at your medical background and previous treatments to help you decide if it is a suitable option.

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.

I am a woman aged 18 or older.
I have a formal diagnosis of anorexia nervosa.
My eating disorder has not improved after standard treatments.
I am able to travel to the clinic for therapy and check-ups over 22 weeks.
I am willing to take part in both talking therapy and a supervised medication session.

Answer every question to see your result.

What does participation involve?

Taking part in the trial lasts around 22 weeks in total. First, you will attend screening visits to check your health and take part in preparation therapy sessions. Next, you will have a dosing day where you take a single capsule of the study medicine in a quiet, comfortable clinic room. Trained therapists will stay with you throughout the entire session to support you. After this, you will have regular therapy visits to discuss your experience and track your progress. The main health checks happen at 10 weeks, with final follow-up assessments taking place at 22 weeks.

Potential risks and benefits

Taking part could help improve your relationship with food and emotional wellbeing, but there is no guarantee of personal benefit. Psilocybin can cause short-term side effects such as nausea, headaches, changes in perception, or feelings of anxiety during the dosing session. However, you will be closely looked after by healthcare professionals in a safe environment. Joining the study is entirely your choice, and you are free to leave at any time without giving a reason and without affecting your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

Is the psilocybin used in the trial safe?

Yes, it is medical-grade psilocybin given in a precise, measured dose within a controlled hospital or clinic setting, with trained professionals monitoring you at all times.

Will I definitely get the psilocybin medicine?

No. You will be randomly assigned to receive either psilocybin or a comparison medicine so the researchers can see if psilocybin works better than the alternative.

What is Acceptance and Commitment Therapy (ACT)?

ACT is a talking therapy that helps you accept difficult thoughts and emotions rather than fighting them, while encouraging actions that match what truly matters to you.

Will I need to stay in hospital overnight?

Dosing sessions usually take place during the day. Once the effects of the medicine have fully worn off and the team is confident you are well, you can go home.

Does it cost anything to take part?

No, taking part in the clinical trial is completely free of charge, including all therapy sessions, assessments, and study medications.