COMP401: Multi-centre clinical trial to investigate psilocybin therapy in anorexia nervosa (COMP360)
Anorexia nervosa is a serious mental illness where people try to keep their weight as low as possible by not eating enough food or exercising too much, or both. It is most common in young women and typically starts in the mid-teens. Globally, about 2.2 per cent of women and 0.3 per cent of men experience anorexia nervosa at some point in their lives, but there are currently no approved pharmacological treatments.
The upcoming trial will compare the effects of 25 mg and 1 mg of investigational COMP360 psilocybin when administered with psychological support, in 60 participants with anorexia nervosa. The King’s IoPPN/South London and Maudsley NHS Foundation Trust partnership is one of four sites that are part of the study, alongside Columbia University Irving Medical Center, University of California San Diego School of Medicine and Sheppard Pratt.
Any changes in symptoms after COMP360 psilocybin therapy will primarily be measured using the Eating Disorder Examination (EDE) interview. Researchers will be investigating whether there is a change from baseline in the EDE global score at week four after the administration of COMP360 psilocybin therapy.
This will be the first study to use myPathfinder, COMPASS’ digital application for supporting patients throughout their COMP360 psilocybin journey. The app is optional for participants in the study, providing engaging education about the therapy model, and with participant consent, collecting real-world data for research on treatment responsiveness.