Stage IV Melanoma

Phase II randomized controlled trial, followed by an open-label extension phase. In the main study, participants will receive either a single high-dose (25 mg) or low-dose (1 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Upon completion of main study, participants who received the low dose will be offered to receive a single high-dose of psilocybin (25 mg) in the context of PEARL therapy (Open label extension study).

Clinical trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation. The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.