Two-dose psilocybin treatment with psychological support for young adults with anorexia nervosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial will enroll 40 young adults (16–35 years) with DSM-5 anorexia nervosa who have had at least one period of remission followed by relapse and a BMI above 16. Participants are randomized 1:1 to receive one of two psilocybin dose regimens alongside structured psychological support or to continue treatment as usual, with careful safety monitoring. The protocol includes fMRI scans and blood biomarker measures (including BDNF) to explore changes in brain connectivity and potential mechanisms of action. Primary outcomes focus on safety and change in eating-disorder symptoms over follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission.
* Have experienced at least one period of weight restoration to a minimum BMI of 17 followed by subsequent weight loss.
* 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.
* 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)
* Ongoing treatment with medications that have clinically relevant 5-HT2A-receptor antagonistic properties and are therefore expected to directly block or substantially interfere with the pharmacodynamic effects of psilocybin. Such medications require an appropriate washout period prior to psilocybin administration, based on pharmacokinetic properties and clinical judgement. Medications without direct 5-HT2A-antagonistic effects are not excluded on this basis.
* BMI \> 21.0 for ≥ 6 consecutive months within the 12 months prior to screening, as documented in medical records.

Where it's running

• Psykiatrikliniken, Baravägen 1
  Lund, Sweden Recruiting

Study contacts

• Principal investigator: Pouya Movahed Rad, Associate Professor — Department of Clinical Sciences, Lund University, Sweden
• Study coordinator: David Sjöström, MD, PhD-student
• Email: david.sjostrom@med.lu.se
• Phone: +46739075390

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Narrative medicine workshops to support teens and young adults with anorexia nervosa (virtual)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.