CAPSI - Cancer related major depression treated with a single dose of pslilocybin - a randomised placebo controlled double blind clinical trial

Background: The age standardised rate of yearly new cancer cases is 190/100 000 globally, by WHO. 30-40% of these will develop depression. There is currently no specific antidepressant treatment regime implemented in the cancer population.

This is in spite of the specific needs given by concurrent cancer treatments, limited quality of life from the cancer per se and the often limited life expectancy from a cancer disease.

A single dose of psilocybin combined with 3 hours of psychological support has shown rapid (within days) and long term (months or years) antidepressant effect in several small studies in different cancer populations. Large, well designed RCTs are still lacking, as is response predictors for treatment guidance.

I am PI of the first RCT of psilocybin treament of depression in Sweden, expected to end randomisation in june 2022.

CAPSI: 100 patients with cancer and depression will be randomised to psilocybin or active placebo (2:1) at 4 different regions in Sweden during 2024-2025. Primary end point is depressive symptoms 6 weeks post dose and follw up is 6 months.

All subjects will undergo EEG and blood sampling, a subsample (n=50) will also undergo MEG and fMRI, and 25 of them also PET, in order to develop a EEG proxy response signature. Together with markers in blood we will develop a predictor model for psilocybin treatment response.

All data will be used to motivate a phase three study with the same PICO and further development of the response markers.