FDA Psilocybin Mushroom Study Could Help Millions with Treatment-Resistant Depression

by Vins
Published: Last Updated on

Treatment-resistant depression is a huge unmet need, affecting 100 million people around the world who do not respond to existing treatments. Depression is one of the fastest growing health problems and the leading cause of ill-health and disability worldwide. The US Food and Drug Administration (FDA) has given Compass Pathways, a life sciences company, “Breakthrough Therapy” approval to dose patients with psilocybin (psychedelic mushrooms) in the first large-scale psilocybin therapy clinical trial for treatment-resistant depression. The trials will take place in Europe and North America during 2019.

The “Breakthrough Therapy” designation is a program designed to expedite the approval process for drugs that have proved promising in treating serious conditions. If the FDA approves psilocybin as a medicine, the drug will be removed from Schedule I of the Controlled Substances Act, which is supposed to be reserved for drugs that have no accepted medical use.

Mushroom-based therapy was initially observed in patients suffering from alcoholism or cancer. The study showed to have a long-term impact on people; one treatment completely reduced depression and anxiety scores, from people being very clinical to reaching remission. Six months later, 60-70% of people are in remission from a single treatment.

It should be clear that psilocybin is not without risks of harm, which are greater in recreational than medical settings, and less harmful than most other legal and illegal drugs. Studies in animals and humans both show low potential for abuse. When rats push a lever to receive psilocybin, they don’t keep pushing the lever like they do for cocaine, alcohol, or heroin. When it comes to human studies, people typically report using psilocybin only a few times across their lifetime.

The news suggests that the FDA has grown willing to look at psilocybin from the perspective of science and public health, rather than a stance of fear or misunderstanding. This change has been slow, as the psychedelic heyday of the 1960s sparked a culture of fear around psychedelic drugs, which meant mainstream scientists couldn’t touch them for decades. Yet these approved studies have the potential to facilitate innovative therapeutic breakthroughs by replacing fear and misinformation with scientifically-based conclusions and facts.

FDA approval for psilocybin clinical trials was covered in many independent media sites. However, the New York Times is the only corporate news source that covered this story, and the information provided was under-reported and minimal—failing to mention the powerful implications of what these approved trials mean. The Times story foregrounded irrelevant information; highlighting cultural trends, i.e. how micro-dosing is being popularized in a CBS television show about Silicon Valley tech people, and how a doctor volunteered to work in the “bad trip” tent at Burning Man.


Erin Brodwin, “A Team of Johns Hopkins Researchers is Calling for Magic Mushrooms to be Made Legally Available as Medicine,” Business Insider, October 11, 2018, https://www.businessinsider.com/johns-hopkins-researchers-magic-mushrooms-psilocybin-medicine-legal-schedule-5-2018-10.

Peter Hess, “FDA ‘Breakthrough’ Ruling on Magic Mushrooms, Explained by Scientists,” Inverse, October 25, 2018, https://www.inverse.com/article/50176-fda-okays-psilocybin-therapy-for-depression.

Johns Hopkins Medicine, “Reclassification Recommendations for Drug in ‘Magic Mushrooms’: If Phase III Clinical Trials are Successful, Researchers Suggest Categorizing the Drug as Schedule IV,” Science Daily, September 26, 2018, https://www.sciencedaily.com/releases/2018/09/180926082159.htm.

Kevin Kunzmann, “FDA Approves Landmark Psilocybin Trial for Treatment-Resistant Depression,” MD Magazine, August 24, 2018, https://www.mdmag.com/medical-news/fda-approves-landmark-psilocybin-trial-for-treatmentresistant-depression.

Student Researcher: Alayah Hodges (San Francisco State University)

Faculty Evaluator: Kenn Burrows (San Francisco State University)