One dose of psilocybin, the active ingredient in Class A psychedelic drugs “magic mushrooms,” has a lasting and significant effect in treating depression that doesn’t respond to other medications, a study has found.
A peer-reviewed mid-stage study published Wednesday in the New England Journal of Medicine found a 25 mg dose of the drug along with psychotherapeutic support “significant[ly]” Reduced symptoms of depression in patients who failed to respond to other medications.
The researchers said the study, led by British pharmaceutical group Compass Pathways, is the largest to date on the use of psilocybin to treat depression and that its findings have paved the way for regulatory approval.
The use of psychedelics to treat mental illness has been widely debated. A very limited number are currently approved for medical use by global regulatory agencies.
But more companies have started exploring different ways to treat mental illness with psychedelics in recent years. The study is a step toward its approval for medical use.
Ketamine is sometimes prescribed “off-label” for treatment-resistant depression, while esketamine, a related drug, is approved as a nasal spray in the UK and US.
Microdosing, or taking small amounts of psychedelics, has also been anecdotally described as beneficial, although researchers say more research is needed on their effects.
James Rucker, a senior lecturer at King’s College London and author of the NEJM study, said the lack of effective treatments for people with treatment-resistant depression could have “serious implications for patients and those around them”.
“Treatment options are often limited, with unpleasant side effects and/or stigma. Therefore, new treatment paradigms are required and clinical exploration of new treatments is important.”
The study was conducted at 22 international sites including King’s College London and the South London and Maudsley NHS Foundation Trust, which specializes in mental health.
About 233 participants with treatment-resistant depression took part in the study and received 1 mg, 10 mg, or 25 mg of psilocybin. Those in the first group acted as controls, and neither researchers nor patients knew what dose strength the latter were taking.
Patients were followed for 12 weeks, with their symptoms assessed the day before administration and at intervals thereafter.
Co-author Nadav Liam Modlin said the research found the drug provided patients with “powerful emotional breakthroughs” and helped them develop “a sense of connection with themselves.”
Some side effects of psilocybin, including headache, nausea, dizziness, fatigue, and suicidal thoughts, have been reported in all dose groups.
Researchers said only one patient had a “bad trip” who was treated with sedatives. The psychedelic portion of the experience lasted hours and was supervised, after which patients were free to go about their business.
Guy Goodwin, Compass’s chief medical officer and co-author of the study, said the company plans to launch its own late-stage, or phase 3, trial this year.
He said the results of the research indicated that psilocybin “has a true pharmacological effect, a finding critical to its future recognition as a new treatment option.”
Dubbed COMP360, the compound has received a breakthrough designation from UK and US regulators that can help accelerate the development and commercialization of new drugs. Compass is also testing it for post-traumatic stress disorder and the eating disorder anorexia nervosa.