Anorexia Clinical Trials

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The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Psykiatrikliniken, Baravägen 1
RECRUITING
Lund
Contact Information
Primary
David Sjöström, MD, PhD-student
david.sjostrom@med.lu.se
+46739075390
Backup
Olea Schau Rybäck, MD, PhD-student
olea.schau_ryback@med.lu.se
+46736698415
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Psilocybin with Psychological Support
This arm will receive two separate doses of psilocybin 25 mg administered four weeks apart, with psychological support, along side treatment as usual. The psychological support includes preparation sessions before, support during, and integration sessions after psilocybin intake.
No_intervention: Treatment as Usual
This arm will receive treatment as usual which includes specialised care offered in an eating disorder unit in Region Skåne, Sweden. If the active treatment arm is determined to be safe, tolerable, and preliminarily effective during the follow-up assessment at 6 months, participants in the control group will have the option to switch to the active treatment while maintaining their usual specialised care.
Related Therapeutic Areas
Sponsors
Collaborators: Lions Forskningsfond Skåne, Sten Theanders fond, NorrskenMind
Leads: Region Skane

This content was sourced from clinicaltrials.gov