Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Psykiatrikliniken, Baravägen 1
Lund, Sweden, 22240
Actively Recruiting
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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