This study focuses on treating people with Treatment Resistant Depression (TRD), a condition where depression symptoms persist despite trying at least two different antidepressant medications. The study will compare two different treatments: psilocybin capsules (PEX010) and personalized brain stimulation therapy called repetitive Transcranial Magnetic Stimulation (rTMS). The purpose is to determine if psilocybin treatment works as effectively as personalized rTMS for people with treatment-resistant depression.
During the study, participants will receive either PEX010 psilocybin capsules containing 25 milligrams of the active substance or a placebo containing maltodextrin. The maximum treatment period with psilocybin is three weeks, with a total maximum dose of 50 milligrams. The study will monitor changes in depression symptoms and overall mental health for 60 days after starting treatment.
The research will use various methods to track participants’ progress, including assessments of depression severity, anxiety levels, and general mental well-being. Brain activity will be monitored using special imaging techniques called functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to understand how these treatments affect brain networks involved in depression.
Italy 
