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The FDA Has Just Granted a Breakthrough Mental Health Therapy Technique

First Posted: Dec 23, 2019 03:01 PM EST
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As of November 22nd, 2019, the Usona institute was granted the ability to legally embark on its mission to collaborate with scientists, clinicians, research centers, expert consultants and philanthropists to pioneer what they think is a breakthrough mental health therapy technique. According to their Executive Director, Bill Linton:

'[Their] objective is to find new and effective methods to relieve anxiety and suffering, and contribute to the understanding of neuroscience and the relationship of the mind and body. This is a frontier of research that will shape our future in important ways that we are just beginning to appreciate."

 

That sounds like a no-brainer, right? Well, the Usona institute has met a considerable amount of resistance from various politicians as well as members of the public for its methodology. It uses psilocybin to treat disorders like Major Depressive Disorder. And its research is so compelling that the US Food and Drug Administration has granted it Breakthrough Therapy Designation.

What is Breakthrough Therapy Designation?

 

The breakthrough therapy designation that was approved means that the Food and Drug Administration have committed as an organization to promoting an efficient development program to use psilocybin to treat Major Depressive Disorder. This acknowledges the unmet medical need in the American population as well as the potential to significantly improve existing therapies. Usona's mission to bring this revolutionary treatment to the forefront of the American mental health fight.

Charles Raison, who is the Director of Clinical and Translational Research at the Usona Institute released a press statement saying:

"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."

The bottom line is that the FDA has done something nobody thought they would do - work towards breaking the stigma of Psilocybin.

Why Is Psilocybin Stigmatized?

Psilocybin has been stigmatized for many years in Western society as it is the primary chemical that creates a recreational effect in those who take what are known as 'Magic Mushrooms'. They have been used in a spiritual and medical context in the non-western world for thousands of years, and The Times of Israel has picked up on some thinkers believing that some Old Testament religious transcendent experiences may have been influenced by the chemical, which is regulated in the United States. Psilocybin is classified as a Schedule I drug and labelled as a hallucinogen under a section of the Comprehensive Drug Abuse Prevention and Control Act. Researchers think that if psilocybin clears phase III clinical trials, it should be re-categorized, but this is at the discretion of the federal government.

What Direction Does This Suggest for the Future?

 

The FDA's approval has allowed Usona to go to phase 2 of their clinical trial PSIL201, which will test the effectiveness of psilocybin treatment with 80 participants across the United States. If it goes well, it could be significant for the 17 million American citizens that suffer from Major Depressive Disorder. If you are personally inspired by the work that goes into aid those suffering from mental health issues, you might want to think about training in a mental health counselling role so that you are in a position to provide supplementary help if this cutting-edge research actually pays off.

Professor of neuropharmaceutocology at Imperial, David Nutt, has likened the stigma placed on this kind of research as akin to banning Galileo's telescope. If that is true, we may be about to reach a paradigm shift, which will open up a lot of opportunity to get involved in either the treatment or the research side of things. If clinical mental health interests you, you might want to consider a masters of clinical mental health counseling, which will provide benefits to your professional foundations even if PSIL201 isn't as successful as the research conducted at Johns Hopkins in the UK.

Depression is the leading cause of disability worldwide and it affects more than 300 million people across the globe. It's a very common disorder for people to want to help out with, and the Usona Research Institute has gotten an influx of support from people on Twitter, as well as emails from scholars and laymen alike commending them on their desire to tackle Major Depressive Disorder. 

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