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

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.

Conditions

• Anorexia Nervosa

Interventions

DRUG

Psilocybin

The intervention consists of two oral doses of 25 mg synthetic psilocybin administered in a controlled clinical setting, combined with psychological support. The psychological support includes preparatory sessions prior to psilocybin administration, support during the drug experience and integration sessions following each dosing session.

Sponsors & Collaborators

• Sten Theanders fond

  collaborator UNKNOWN

• Lions Forskningsfond Skåne

  collaborator UNKNOWN

• NorrskenMind

  collaborator UNKNOWN

• Region Skane

  lead OTHER

Principal Investigators

• Pouya Movahed Rad, Associate Professor · Department of Clinical Sciences, Lund University, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-20

Primary Completion

2026-10-01

Completion

2027-10-01

Countries

• Sweden

Study Locations