Psilocybin Designated As A “Breakthrough Therapy” For Major Depressive Disorder (MDD)
Numerous studies have proven the efficacy of treatment using psilocybin for various mental health disorders including depression.It has now been labelled as a "breakthrough therapy" by the FDA.
The US Food and Drug Administration (FDA) has recently granted psilocybin treatment (the active component of magic mushrooms) a Breakthrough Therapy classification for the second time this year.
They are hoping to accelerate trials that will test its efficacy in treating major depressive disorder (MDD). According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. This new designation of psilocybin as a Breakthrough Therapy for MDD recognizes the hugely unmet medical need in the large population of those who suffer as well as the potential for improvements to the current treatments and therapies. This is being coordinated by a non-profit research organization, the Usona Institue. “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 acknowledgement 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,” says Charles Raison, MD, Director of Clinical and Translational Research at Usona. “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.” The Multidisciplinary Association for Psychedelic Studies (MAPS) has done numerous studies over the years involving psilocybin for treating various disorders including addiction, depression and use in palliative care.
The new status given to psilocybin follows the launch of Usona’s Phase 2 clinical trial, which will involve 80 participants and seven study sites across the US. 2 of the 7 sites are recruiting and the rest should be active within the first quarter of 2020.
The methodology is comparable to other therapeutic studies involving psilocybin — preparatory psychotherapy sessions before the active psychedelic dose is administered, followed by a number of integrative psychotherapy sessions after.
The trial will investigate the effects of a single dose of psilocybin and its efficacy in treating general depressive episodes.
The current Phase 2 trial should be completed by the beginning of 2021 and with the assistance of the Breakthrough Therapy classification from the FDA, it should be able to move into much larger Phase 3 trials, if the results from Phase 2 are positive. “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,” says Raison. In an attempt to treat depression, researchers from Imperial College, London gave 12 patients psilocybin.
The 12 patients who were chosen had been clinically depressed for an average of about 18 years and the results were actually quite remarkable.
The results from the psilocybin treatment actually succeeded the typical pharmaceuticals that are prescribed to treat depression like selective serotonin reuptake inhibitors (SSRIs) and electroconclusive therapy. Just 1 week after taking the magic mushrooms, all 12 patients from the study reported feeling better, and checking in 3 months later, 5 of them were in complete remission. Quite impressive from only one dose. “That is pretty remarkable in the context of currently available treatments,” says Robin Carhart-Harris, a neuropsychopharmacologist at Imperial College, London and first author of the latest study, which is published in The Lancet Psychiatry. Although many people may oppose regulation of this treatment by the FDA, we have to applaud how far this research has come in such a short time. If psilocybin assisted psychotherapy becomes legal, this has the potential to benefit millions who have not benefited from traditional methods of treatment for depression. This groundbreaking research has the ability to save lives. Of course, many have benefited from doing their own research with themselves as guinea pigs, myself included. I am not suggesting anyone try this, as these treatments should be implemented under the guidance of professionals who have the proper tools to assist you through the process. But speaking from experience, there is a tremendous opportunity available here, to help those who are suffering as the experience helps to take you outside of yourself. It often causes a major perspective shift and deep insights into ones life. Of course this isn’t always the case and it is very important to note that psychedelic therapies are not a one size fits all approach and they are not recommended for everyone. Furthermore, it’s simply a tool to be used and perhaps shouldn’t be looked at as a ‘cure.’ Ultimately, we all have to do the inner work in order to feel better instead of constantly relying on something outside of ourselves. Once these laws are passed than this treatment will be more accessible and can be administered responsibly with the assistance of trained professionals. Due to the pressure of mass censorship, we now have our own censorship-free, and ad-free on demand streaming network! It is the world's first and only conscious media network streaming mind-expanding interviews, news broadcasts, conscious shows and personal transformation guides. Click beelow to claim your 50% OFF discount using the code 'BF2019', and watch 100's of hours of conscious media videos, that you won't see anyw.
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References:
- https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
- https://www.usonainstitute.org/
- https://newatlas.com/science/psilocybin-major-depression-mdd-usona-breakthrough-therapy-fda/?fbclid=IwAR3RJd_Zq7F_nKuvhsCFLsQ5kN9o_6AAzqdejjEZd2GUQVbgKQodXWcGaiU
- https://maps.org/research/other-research
- http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(16)30065-7/abstract
- http://www.nature.com/news/magic-mushroom-drug-lifts-depression-in-first-human-trial-1.19919#/b1
- https://www.collective-evolution.com/a/bf2019
