Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa
Research type
Research Study
Full title
Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study
IRAS ID
1004612
Contact name
Guy Goodwin
Contact email
Sponsor organisation
COMPASS Pathfinder Limited
Eudract number
2021-006233-19
Clinicaltrials.gov Identifier
Research summary
The safety and effectiveness of taking COMP360 (study medicine), for participants with anorexia nervosa (AN), will be studied in this Clinical Trial. COMP360 is a synthetic form of psilocybin, a chemical compound found in some species of mushrooms (magic mushrooms). COMP360 works in parts of the brain which are linked to the regulation of mood.
Approximately 60 participants, over 18 years will participate in United Kingdom and United States.
The Trial is divided into the below periods:
• Screening period (to check eligibility to join the study)
• A baseline visit (another check to ensure that participants can receive the study medication)
• Treatment/Dosing day – there will be 2 treatment groups (1 group will receive a higher dose and the other a lower dose). Participants will have a 75% chance of receiving the higher dose compared to the lower dose and assignment to the groups will be based on a random computer assignment.
• Safety Follow-up period (to check your overall health and safety)The study medicine comes in capsule form and is to be taken orally with water in clinic with psychological support. Side effects will be monitored throughout the study.
Participation in the study will last approximately 18 weeks. Participation is voluntary.
Participants will be expected to attend clinic visits whereby study assessments will take place e.g., blood and urine collection, vital signs monitoring and completion of questionnaires.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0075
Date of REC Opinion
17 Feb 2022
REC opinion
Further Information Favourable Opinion