A magic mushroom has been given FDA clearance to be used as a therapy for treatment-resistant depression.
Technically, shrooms have been stamped with the FDA designation of “Breakthrough Therapy,” meaning you won’t be able to run off to Walgreens and buy a bag of caps quite yet. This designation indicates the FDA supports early research that should translate into real-life clinical outcomes.
The life science company, COMPASS Pathways, is responsible for bringing this FDA badge of legitimacy to psychedelic shrooms (aka “Psilocybin mushrooms,” which are mushrooms belonging to a group of fungi containing psychedelic compounds like psilocybin, psilocin and baeocystin).
So, yes, “psilocybin therapy” is still being tested but the FDA’s sort-of approval is huge.
It means that preliminary clinical evidence has already shown promise that magic mushrooms could be a substantial improvement over current therapies available for depression.
According to COMPASS, psilocybin therapy combines a dose of psilocybin (a psychoactive medicine and the active ingredient in “magic mushrooms”) coupled with psychological support.
"The participants will be given one of three doses of psilocybin, and are likely to have a psychedelic experience… Patients are carefully screened for contraindications, and prepared and supported before, during and after the psilocybin session by specially trained therapists. Patients are never given psilocybin to take on their own and the therapy is as important to the treatment as the drug," Tracy Cheung of COMPASS tells Rooster.
A number of research institutes and experts in the field of medicine including teams in the US, UK, Switzerland, Johns Hopkins University, New York University and Harbor-UCLA have worked for years to uncover evidence of magic mushrooms being a no-joke option for those people who show no response to current treatments for depression.
With the FDA on their shoulders, COMPASS Pathways is now running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression, to take place in both Europe and North America over the next year.
So instead of sitting at an office desk, participants will be noshing shrooms and, probably, feeling rad.
In 2015, Imperial College London (ICL) did a study that “provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as a treatment for treatment-resistant depression,” says Dr. Robin Carhart-Harris, Head of the Psychedelic Research Group at ICL.
Earlier still in 1993, Heffter Research Institute performed clinical studies on shrooms. Their Chairman of the Board, Dr. David Nichols says, “We are delighted that psilocybin is being recognized as a Breakthrough Therapy and look forward to continuing our work with researchers and partners around the world so that we can alleviate the suffering caused by mental illness."
What happens next?
“The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering from depression as quickly as possible,” says Executive Chairman of COMPASS Pathways, George Goldsmith.
At the moment, it seems psilocybin therapy will be positioned as a last resort for those who do not respond to other treatments. I, for one, would much rather take natural mushrooms that synthetic pills but hey, I was raised off-the-grid in the middle of the desert. But I’m far from alone in thinking magic mushrooms could be one of the most exciting medical breakthroughs of the century.
COMPASS estimates about 100,000,000 people around the world do not respond to existing treatments, and believe that number will only get higher as “depression is one of the fastest growing health problems we face today, and the leading cause of ill-health and disability worldwide,” COMPASS said in a press release.
Writer Aldous Huxley was right all along in saying, “The man who comes back through the Door in the Wall will never be quite the same as the man who went out. He will be wiser but less sure, happier but less self-satisfied, humbler in acknowledging his ignorance yet better equipped to understand the relationship of words to things, of systematic reasoning to the unfathomable mystery which he tries, forever vainly, to comprehend.”