Actively Recruiting

Phase 2
Age: 16Years - 35Years
All Genders
NCT07169747

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

Led by Region Skane · Updated on 2026-03-06

40

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

S

Sten Theanders fond

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of anorexia nervosa according to DSM-5
  • At least one period of remission with minimum BMI of 17 followed by relapse
  • Age between 16 and 35 years
  • Body mass index (BMI) greater than 16
  • Stable contact with a psychiatric unit
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • History of psychosis, bipolar disorder, substance use disorder, or family history of psychosis or bipolar disorder
  • Refusal to use birth control
  • Lifetime use of psychedelic drugs
  • Unable to stop medications that interfere negatively with study drug (5-HT2A-antagonist requires two-week washout)
  • Cardiovascular conditions including resting systolic blood pressure over 140 mmHg or diastolic over 90 mmHg, arrhythmias, tachycardia, QT prolongation, stroke, or myocardial infarction
  • Seizure disorders or history of epilepsy
  • Diabetes mellitus
  • Positive drug tests
  • Suicidal intent
  • Allergy or intolerance to study drug content
  • Blood or needle phobia
  • For MRI part: metal pieces in the body (contraindicated by fMRI)
  • Any other significant medical condition that may pose risk or interfere with study results
  • Care under the Swedish Compulsory Psychiatric Care Act (LPT)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Psykiatrikliniken, Baravägen 1

Lund, Sweden, 22240

Actively Recruiting

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Research Team

D

David Sjöström, MD, PhD-student

CONTACT

O

Olea Schau Rybäck, MD, PhD-student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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