EPIsoDE - A Phase II Clinical Trial to Investigate the Efficacy and Safety of Psilocybin in Treatment-Refractory Unipolar Depression

Depression is one of the most common illnesses of all. Resistance to therapy is also common. In the approval and effectiveness studies of the various medications, a third to half of the patients do not respond to treatment lasting several weeks. Despite intensive research, there is still a lack of effective therapeutic approaches in the event that the previously approved medications do not work.

A possible approach in the treatment of therapy-resistant depression is the use of psilocybin. Psilocybin is a naturally occurring substance from special types of mushrooms. In humans, psilocybin has a psychoactive effect and can produce euphoria, physical lightness and hallucinations. In addition to findings from the 1950s and 60s, more recent Clinical Trials Using Psilocybine suggest the effectiveness and safety of psilocybin in the treatment of treatment-resistant depression, depression and anxiety associated with terminal illnesses, obsessive-compulsive disorder and substance use disorders. The aim of the project is a bicentric clinical study with patients with treatment-resistant depression. The aim of this study is to demonstrate the safety of the application and to obtain initial indications of the effectiveness of the therapy.

As is the case with psilocybin in the treatment of depression, there is no immediate commercial interest from pharmaceutical companies in further clinical development for many new, potentially effective therapeutic approaches due to a limited range of applications or high scientific and technical risks. One of the central challenges is to investigate such therapeutic approaches so that patients can benefit from them as quickly as possible. In the “Early Clinical Studies” funding measure, the BMBF therefore promotes the implementation of science-initiated early clinical studies up to Phase II and helps ensure that new therapeutic approaches are pursued further.