Magic Mushroom Drug Trial Approved For Depression by FDA

Magic Mushroom Drug Trial Approved For Depression by FDA

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Magic Mushroom Drug Trial For Depression Approved by FDA

The FDA has approved, for treatment resistant depression, a new drug trial using psilocybin, the psychoactive chemical found in magic mushrooms.

A company named Compass Pathways has recieved the go-ahead to conduct clinical trials for patients suffering with treatment-resistant depression.1

Compass Pathways, announced on 22nd August 2018, that the FDA had given them permission for a new treatment for depression involving psilocybin, or “Magic mushrooms.” 2

Compass Pathways is a company founded in London, England, in 2016 that researches life sciences.

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The trial will be in phase IIb, and will feature a dose-dependent study with 216 participants taking part in 12 to 15 research sites across Europe.

Trials will begin in the UK and US in a few weeks, and as further regulatory approval is acquired, sites in other countries will also join the trials.

Psilocybin Therapy Clinical Trials

The new TMS treatment will require less treatments than with traditional approach, as well as significantly reducing the time for treatment itself.

Psilocybin therapy uses small doses of psilocybin with psychotherapy, and has shown great promise of effectively and safely treating depression in scientific studies in the UK and US. 3

When the trial is successful, it will then be followed by phase III trials, such as the ones MDMA is going through now.

Chairman of COMPASS Pathways, said,

“We are excited to be starting this landmark trial which has the potential to transform lives. 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.”

And according to Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS:

“The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe. and North America. working together with the goal of helping patients suffering with treatment-resistant depression.”

COMPASS Pathways was founded in 2016 to study new methods that would allow patients access to scientific-based innovation in mental health.

According to COMPASS Pathways:

We are developing psilocybin therapy through a late-stage clinical trial in Europe. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology.

The patients in this trial will also be receiving “Psychotherapy” in addition to magic mushrooms. Researchers have known for some time that psilocybin and other direct serotonin agonists coupled with psychotherapy showed great proimse as effective and safe treatments for extreme depression.

With Psilocybin treatment, researchers noticed reduced blood flow to the amygdala, which was correlated with a decrease in depressive symptoms in all subjects only a week after treatment, and in almost half of the patients five weeks later.

They have also reported that the FDA is thinking about approving the drug MDMA for the treatment of PTSD, thanks to, because it increases feelings of trust and emotions of compassion.4