Clinical Trial Examines Synthetic Psilocybin as a Treatment for Severe Depression

Participants in a double-blind trial on depression found temporary relief with a synthetic formulation of psilocybin, COMP360.

Individuals suffering from severe depression may find relief from just a single dose of a synthetic version of psilocybin, or “magic mushrooms,” according to a new study published this week. 

The findings, which were published Wednesday by The New England Journal of Medicine, come from a double-blind trial involving 233 “randomly assigned adults with treatment-resistant depression [who received] a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support.”

“In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects,” the authors wrote in their conclusions, adding that “larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder.”

They said that “adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness, while “suicidal ideation or behavior or self-injury occurred in all dose groups.”

Dr. Guy Goodwin, a professor emeritus of psychiatry at the University of Oxford in the United Kingdom and a co-author of the study, said that 25 MG of synthetic psilocybin, COMP360, provided “an immediate, fast, rapid-acting, sustained response,” as quoted by CNN.

“This drug can be extracted from magic mushrooms, but that is not the way our compound is generated. It’s synthesized in a purely chemical process to produce a crystalline form,” said Goodwin, the chief medical officer of COMPASS Pathways, which produces COMP360 and also conducted the study, as quoted by CNN.

CNN has more background on the study:

“The clinical trial occurred at 22 sites in the United States, Canada, the UK and seven countries in Europe. The study was designed to test the safety of different dosages of the proprietary version of psilocybin. The 233 study participants had treatment-resistant depression, which can only be diagnosed after a person fails to respond to two courses of antidepressants. Of the 9 million people in the US with medically treated depression, 3 million patients are resistant to treatment, studies have estimated. Globally, some 100 million people have treatment-resistant depression, Goodwin said. People with the condition are at a high risk of physical illness, disability, hospitalization and suicide, the study said.”

Research on the therapeutic benefits of mushrooms has sprouted over the last decade, with psilocybin emerging as a viable (and perhaps safer) alternative to prescription antidepressants. 

Researchers at the University of Guelph (UG) in Ontario, Canada announced last month that they will be conducting a study on mushrooms, becoming the first Canadian university to engage in such research.

“We are very excited about this approval as it will allow us to study these psychedelic mushrooms to better understand their biology and genetics, examine what other functional compounds they might contain, and provide well-characterized and chemically consistent material for preclinical and potentially clinical evaluation,” one of the researchers, Dr. Max Jones, said in the announcement.

Jones said the study aims to look at the hundreds of varieties of mushrooms that are capable of producing psilocybin. 

“Those species aren’t that closely related; they’re diverse,” Jones said in the announcement at the time. “So that makes scientists like me wonder: what else are these mushrooms producing? If you have 200 species producing a compound that affects the human brain, it’s likely they are producing other interesting compounds, too.”

“There is a real need for a public supply of these mushrooms,” Jones added. “We aim to create a supply of mushrooms to be used for preclinical and perhaps clinical trials in which the genetics and cultivation methodologies will be fully disclosed to researchers and the public.”

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