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FDA grants Breakthrough Therapy designation to psylocibin as therapy for TRD

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Research into psylocibin's efficacy in treating treatment resistant depression has been conducted in the US and UK before. This past week the US Food and Drug Administration granted the Breakthrough Therapy designation to Compass Pathways. 

This is news because now the company can perform larger clinical trials both in UK and US and if the results are promising, speed up access to patients by partnering with the FDA as opposed to fighting it. 

My diagnosis is MDD/TRD so I'll be following this closely. 

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It's time to update this as clinical trials involving psilocybin are underway in the US, UK, Denmark, Finland and Switzerland. Major Depressive Disorder is the focus of many of the studies but also OCD, chemical dependency and other conditions.

Most of the trials are placebo-controlled and in a couple of them, Ketamine is being used as the placebo which I think is interesting.

Some trials have completed, others are recruiting now or will be later in 2019. 

The inclusion and exclusion criteria for any clinical trial is rather lengthy, the researchers want to mitigate risks. If interested, you can find these studies on the websites clinicaltrials.gov and clinicaltrialsregister.eu with the search term psylocibin.


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