This clinical trial focuses on studying a medication called CYB003 for people with Major Depressive Disorder. The medication contains deupsilocin besilate and comes in capsule form that is taken by mouth. The study aims to examine how long the medication’s benefits last after initial treatment and whether additional doses might help maintain its effectiveness.
The study is designed as a long-term extension trial, which means it continues to follow participants who have completed previous studies of the same medication. During the trial, participants may receive up to three additional doses of CYB003 while continuing their regular antidepressant medication. The maximum daily dose of the study medication is 16 milligrams, and the treatment period can last up to 43 days.
Throughout the study, researchers will monitor how well participants maintain their improvement in depression symptoms and how quickly symptoms might return, if at all. They will also track whether participants who didn’t respond well to the initial treatment might benefit from additional doses. The study will evaluate both the safety of the medication and how well it works over a longer period.
Czechia 
Germany 
Greece 
Ireland 
Poland 
