FDA approves first FPSA trial on magic mushrooms as depression treatment!

on . Posted in Articles of Interest

LONDON, England (PNN) - August 24, 2018 - The Food and Drug Administration today approved the first Fascist Police States of Amerika clinical trials using psilocybin from magic mushrooms to treat depression.

Psilocybin is one of several psychedelic drugs that have recently reemerged from the shadows as they show promise to treat mental illnesses and addictions.

The Peter Thiel-backed health and life sciences startup, Compass Pathways, is the latest to test the “brain-resetting” power of the schedule I drug on patients.

Already approved in three other countries, the first wave of the trial is set to begin in the Fascist United Kingdom later this month with studies in Canada, the Netherlands, and the FPSA to follow.

Psychedelics may be the latest novel approach to mental health making headlines, but they are far older than the most widely accepted treatments for illnesses like depression and anxiety.

Portrayals in stone carvings and rock paintings that predate recorded history suggest that people discovered the hallucinogenic powers of magic mushrooms as early as 9000 BC.

The fungus was once the centerpiece of religious ceremonies, but in 1959, a chemist at the pharmaceutical company Albert Hofmann was able to identify and separate out the psychoactive compound in mushrooms: psilocybin.

For a brief period between 1961 and 1965, Sandoz sold the compound as a psychotherapeutic medicine called Indocybin.

It was quickly discontinued because it was widely misused to “trip”, or hallucinate.

Psilocybin has since been tightly regulated in the FPSA where it is treated as equally illicit to heroin.

Until recently the properties of the compound were hardly studied except by fringe groups.

But as depression continues to surge and hinder the lives of some eight percent of Amerikans, scientists are looking at increasingly inventive options to treat the disorder.

We are still mapping out depression and the chemical, structural and environmental factors that cause it, but the involvement of serotonin is fairly undisputed at this point.

And psilocybin is shaped similar to the regulating neurotransmitter, and binds to some of the same receptors in the brain.

This suggested to researchers that it might have a role to play in the treatment of depression.

The most commonly prescribed class of antidepressants are SSRIs, or selective serotonin reuptake inhibitors. The idea behind these drugs is that they prevent the neurochemical from being reabsorbed too quickly, leaving more of it available to the brain.

In particular, this is thought to help the amygdala, the brain's control center for emotions, from overreacting to negative experiences and feelings.

The drugs are fairly effective for many people, but the treatment can come at the cost of positive emotions as well, leaving patients feeling a bit numbed.

Paradoxically, psilocybin appears in brain scans to treat depression by making the amygdala more responsive to emotions, but somehow patients are better able to process them and feel relief from their depressive symptoms weeks later.

Other research has suggested that the drug “resets” neural circuits that create negative feedback loops in patients' brains.

The growing body of evidence supporting the usefulness of psilocybin means that it has made its way from lab tests to larger and larger clinical trials.

In 2016, scientists at New York University did a trial with 29 patients who had developed depression related to advanced cancers.

Over the entire eight weeks the researchers watched them, the patients who got the drug had marked improvements in their depression symptoms.

The NYU study was notable because it was double blinded, meaning that neither the patients nor the researchers knew which participants had gotten psilocybin and which had gotten a placebo.

Compass Pathways newly approved study will be the largest of its kind to date.

The startup is in the process of recruiting patients who have tried multiple antidepressants and gotten little to no relief.

Eventually, 216 participants will be recruited from several countries, including at least the FUK, the Netherlands, Canada, and now the FPSA.

Researchers at each of the 12 to 15 study sites will administer a single dose of psilocybin “in a quiet, ambient room with two therapists/chaperones present for the entire session, which will last up to six hours,” SAID Compass's Tracy Cheung in an email.

For 12 weeks, the research team will continue to check on each patient.

“We are excited to be starting this landmark trial, which has the potential to transform lives,” said Compass's chairman and co-founder George Goldsmith in a statement.

If all goes well, the study could open the door to a phase III clinical trial, comparing psilocybin treatment not to a control, or placebo medication, but to currently approved and prescribed drugs.

“Depression is the leading cause of ill health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it," said Goldsmith.

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