RecruitingPhase 2

Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa

Sweden40 participantsStarted 2026-04-20

Plain-language summary

The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.

Who can participate

Age range

16 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of AN per DSM-5 * Have experienced at least one period of remission (minimum BMI 17) followed by a relapse * Age 16-35 * BMI \>16 * Stable contact with a psychiatric unit * Ability to provide informed consent Exclusion Criteria: * Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use, unable to washout ongoing medications\* that would interfere negatively with the study drug * Cardiovascular conditions * Resting systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg at screening or baseline * Clinically significant arrhythmias, tachycardia and QT prolongation * History of stroke, myocardial infarction, or other significant cardiovascular events * Seizure disorders or history of epilepsy * Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia * Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion * Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results * Care under the Swedish Compulsory Psychiatric Care Act (LPT) * 5-HT2A-antagonist need two weeks washout

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the safety and tolerability of psilocybin 25 mg in young adults with anorexia nervosa, as measured by incidence of adverse events (AEs) and serious adverse events (SAEs).

Timeframe: From enrollment to the end of trial 12 month post-baseline.

Trial details

NCT IDNCT07169747

SponsorRegion Skane

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

David Sjöström, MD, PhD-student

+46739075390 david.sjostrom@med.lu.se

View on ClinicalTrials.gov More Anorexia Nervosa trials