In a bit of a pleasant surprise, the U.S. Food and Drug Administration (FDA) has approved a “breakthrough therapy” for psilocybin clinical trials. This action is meant to accelerate the process that normally takes a long time. This clinical trial will be administered by the non-profit medical research organization, the Usona Institute who will be researching Major Depressive Disorder (MDD).
Usona Institute Director of Clinical and Translational Research, Charles Raison, comments:
The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgment that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies. Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.
This is going to be Phase 2 of Usona’s clinical trial, PSIL201, it will include around 80 participants and will take place at 7 locations in the U.S. Two of the stations are already accepting applicants, the other 5 sites will begin shortly.
This is a very important study as more than 17 million people in the U.S. are said to suffer from MDD and more than 300 million people around the world. Psilocybin offers more of a possible long-term solution than pharmaceutical masking drugs.
Psilocybin has been used for centuries and has been shown in shows such as Psychedelica, that it helps to rewire the brain. It allows our brain receptors to communicate with other parts of the brain than would normally happen. This allows different communication where self-healing can take place. While people have often thought of it just as magic mushrooms or a recreational drug, this is a plant medicine and I for one am happy this clinical study has been approved.
For more information on Usona’s ongoing clinical trials, you can visit usonaclinicaltrials.org.
