A clinical trial to assess safety and efficacy of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa in adults

This single-blind, phase II trial (n=30) will assess the safety and efficacy of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa in adults.

The intervention involves three oral doses of psilocybin administered with psilocybin-assisted psychotherapy, including preparatory and integration sessions. Each participant will receive three psilocybin sessions, with doses ranging from 1 mg to 25 mg.

The primary outcomes include changes in core eating disorder psychopathology and motivation to change, assessed by various scales. Secondary outcomes encompass the effects on depression, anxiety, quality of life, cognitive flexibility, and more.

Eligible participants must be females aged 21 or above, meeting DSM-5 criteria for anorexia nervosa, among other criteria. The trial is conducted in Australia, with the University of Sydney as the primary sponsor and Imperial College London as a collaborator.

Recruitment is anticipated to begin in July 2023, with the last participant enrolled by December 2024 and data collection completed by December 2025. Funding is provided by the Department of Health, Medical Research Future Fund (MRFF) Innovative Therapies for Mental Illness Grant. The principal investigator is Prof Sloane Madden.

Topic Eating Disorders
Compound Psilocybin
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 July 2023
End date 30 December 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 30
Sex Female
Age 21- 65
Therapy Yes

Trial Details

This study aims to: 1. Demonstrate safety and preliminary efficacy of psilocybin-assisted psychotherapy in reducing core eating disorder psychopathology and increasing motivation to change in AN as assessed by the EDE/EDE-Q and RMQ 2. Evaluate effects of psilocybin on depressive, anxious and obsessional symptoms, cognitive flexibility, quality of life and alliance between therapist and patient.

NCT Number ACTRN12623000357651

Sponsors & Collaborators

University of Sydney
The University of Sydney is Australias oldest university. At the psychopharmacology laboratory, researchers have conducted some research with psychedelics.

Imperial College London
The Centre for Psychedelic Research studies the action (in the brain) and clinical use of psychedelics, with a focus on depression.

Data attribution

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