Psilocybin Alpha reports..
The German Government has approved a Phase 2b study on psilocybin for treatment-resistant depression, and is providing millions of Euros to this latest psychedelic research project.
Germany’s Federal Institute for Drugs and Medical Devices has approved a study on the Efficacy and Safety of Psilocybin in Treatment-Resistant Depression, known by the shorthand ‘EPIsoDE’. This marks the first psilocybin depression study in Germany since the 1970s.
The phase 2b two-centre study will investigate the safety and efficacy of psilocybin in a controlled, randomised double-blind design. Specifically, a therapeutic dose of psilocybin (25mg) will be compared to an active control dose of psilocybin (5mg) and niacin. A second therapeutic dose will be administered six weeks after the first. The study expects to have 144 participants.
