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.
This approval is the culmination of two years’ work, with Dr. Gerhard Gründer of the Central Institute of Mental Health Mannheim heading-up the team. The Mannheim group will work with researchers from the Department of Psychiatry and Psycotherapy at Charité Campus Berlin Mitte and the MIND Foundation.
Dr. Gründer described the approval as “a milestone for German psychiatry, from which I expect not only impulses for treatment research, but also insights into the nature of mental illness and the foundations of consciousness.”
Earlier this year, we learned that the German Government agreed to fund the study, a major success in itself. Psilocybin Alpha understands that the Government, via the Ministry of Education and Research, is to provide in excess of €2 million for the study. Last month, Havn Life announced their support for the research via a $20,000 donation.
The psilocybin used in the study will be provided by the Usona Institute, who are progressing with their own study of psilocybin for depression.
This is certainly an important milestone for psychedelic research in Germany and Europe, as expressed by Gründer:
Our study will be one of the largest and most extensive that has ever been carried out with a psychedelic. That a German government is making progress in promoting this research is a great signal to the world.Dr. Gerhard Gründer