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

The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults

This study will see if two doses of psilocybin given with psychological support are safe and help reduce anorexia nervosa symptoms in young adults ages 16–35.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 16 Years to 35 Years
• Sex: All
• Sponsor: Region Skane (other)
• Locations: 1 site (Lund)
• Trial ID: NCT07169747 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are 16–35-year-olds with DSM-5 anorexia nervosa who have experienced at least one remission followed by relapse, have BMI >16, maintain stable contact with psychiatric services, and can provide informed consent.

Not a fit: People with psychosis or bipolar disorder, substance use disorder, a personal or family history of psychosis, significant cardiovascular disease, active suicidal intent, very low BMI (<16), or those unable to wash out interfering medications are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, this approach could provide a new, mechanistically different treatment that helps reduce symptoms and support recovery in young people with anorexia nervosa.

How similar studies have performed: Early psilocybin trials have shown promising effects in depression and other psychiatric conditions, but randomized evidence specifically in anorexia nervosa is very limited and the approach remains experimental.

Eligibility criteria

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

Where this trial is running

Lund

• 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

Conditions: Anorexia Nervosa, Psilocybin, Young adults, fMRI, BDNF, Adolescents