FDA Commits To Study Psychedelic Psilocybin As “Breakthrough Treatment” For Severe Depression

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The US Food and Drug Administration (FDA), is now looking at psilocybin – a hallucinogenic chemical found in psychedelic mushrooms – as a “breakthrough treatment” for major depressive disorder (MDD), putting it on the “fast track” for future clinical studies.

The designation was granted after a request from the Usona Institute, a nonprofit medical research group conducting research on psilocybin, in determined that psilocybin’s has the potential to improve existing therapies.

Mayo Clinic MDD has determined that anxiety and depression impacts more than 16 million people in the US and is the leading cause of disability in those between the ages of 15 and 44, according to the Anxiety and Depression Association of America. It is estimated that 322 million people globally live with some type of depression. Previous studies have shown that magic mushrooms can ease severe depression and may “reset” the brains of people with depression without the emotional numbing associated with some traditional antidepressants. 

Cancer patients taking psilocybin to treat depression show reduced symptoms weeks after treatment following a ‘reset’ of their brain activity. Psilocybin is the psychoactive compound that occurs naturally in magic mushrooms. The findings come from a study in which to treat a small number of patients with depression in whom conventional treatment had failed.

Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms

In a paper, published in the journal Scientific Reports, the researchers describe patient-reported benefits lasting up to five weeks after treatment and believe the psychedelic compound may effectively reset the activity of key brain circuits known to play a role in depression.

Magic “Psilocybin” Mushrooms Reset Brains And Eliminate Depression!

Two separate research teams at New York University and John Hopkins released studies last week identifying a remedy to this toll—a psychedelic mushroom trip, experienced under controlled conditions with a therapist. In June, author Michael Pollan released a podcast on the history and science of hallucinogenic compounds like mushrooms (which contain psilocybin). In the segment, Pollan explained that their ability to generate altered mental states has

caused doctors to turn away from their potential as medicines. They have shown remarkable promise for treating cancer stress for decades; research was just paused when the Controlled Substance Act made them illegal.

In a 2015 New Yorker piece, Pollan detailed how the gradual easing of the federal government’s drug prevention efforts have opened up a window for research—a window that young researchers have been taking advantage of. Both the NYU and John Hopkins study focused on a group of cancer patients suffering from anxiety and depression and used the “double-blind” method. Neither the subjects nor their therapists knew who got the real drug and who got the placebo.

“Single moderate dose” of psilocybin does the trick

The NYU team divided nearly 30 patients into two groups—half of which got a “single moderate dose” of psilocybin, and the other half of which got a dose of niacin. After seven weeks, they switched which group was receiving what. Throughout the entire process, they received psychotherapy. The team was able to conclude that a single dose of psilocybin “produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improve spiritual well-being, and increased quality of life.”

At John Hopkins, the control group received a tiny “placebo-like” dose of psilocybin instead of niacin. After five weeks, they crossed over. Research was conducted in a “living-room-like environment with two monitors present.” For most of the sessions, participants were encouraged to lie down on a couch and use an eye mask to block external visual distraction while listening to music. Researchers at John Hopkins concluded that after getting a dose of mushrooms, patients demonstrated “large decreases” in depression and anxiety, “along with increases in quality of life, life meaning, and optimism, and decreases in death anxiety.”

This could be a breakthrough in cancer treatment. Today, cancer patients are often treated with conventional pharmaceuticals to treat depression and anxiety, with have short-lived benefits and “significant side effects.” A single dose of psilocybin, on the other hand, usually produced a “psilocybin-induced mystical experience.” While some patients experienced mild “bad trips”—nausea or psychological discomfort—none of these adverse episodes were marked ‘serious.’

The positive side effects were incredible, on the other hand. One of the NYU researchers noted that study participants reported “going out more, greater energy, getting along better with family members, and doing well at work” and “unusual peacefulness and increased feelings of altruism.”

Threatening substances

It’s important to note that these patients are not advised to take psilocybin “without supervision by a physician and a trained counselor.” And there are many barriers to bringing psilocybin to the market as an approved pharmaceutical.

“They’re very threatening substances to institutional power, whether it’s religious institutions or the state,” Pollan concluded.

Photo: Psilocybe cubensis, a common variety of psilocybin-containing mushroom Credit: Paul Stamets