A peer-reviewed, mid-stage trial published in the New England Journal of Medicine suggests one dose of psilocybin, the active ingredient in the psychedelic drug “magic mushrooms”, has a sustained and significant effect in treating cases of depression that are unresponsive to other drugs. The study found one 25mg dose of the drug, alongside psychotherapeutic support, “significant(ly)” reduced symptoms of depression in patients who did not respond to other medicines.
Researchers said the study, led by UK-based pharmaceutical group Compass Pathways, was the largest to date on the use of psilocybin as a treatment for depression and that its findings paved the way for regulatory approval. The use of psychedelics to treat mental health conditions has been widely debated. Currently, a very limited number are approved by global regulators for medical use. However, more companies have in recent years begun to explore different ways of treating mental health conditions with psychedelics.
Ketamine is sometimes prescribed “off-label” in treatment-resistant depression, while esketamine, a related compound, is approved in the UK and US as a nasal spray. Senior lecturer at King’s College London and an author of the NEJM study, James Rucker, said the lack of effective treatments available to people with treatment-resistant depression could “seriously impact on patients and the people around them.”
He said, “Treatment options are often limited, with troublesome side effects and/or stigma. Therefore, new treatment paradigms are needed, and clinical research of new treatments is important.” The study was conducted across 22 international sites, including KCL and the South London and Maudsley NHS Foundation Trust, which specialises in mental health. Some 233 participants with depression resistant to treatment took part in the study, receiving 1mg, 10mg, or 25mg of psilocybin. Those in the first group acted as a control group, and neither researchers nor patients knew what strength of dose the latter took.
Patients were tracked for 12 weeks, with their symptoms rated the day before administration and at intervals thereafter. Co-author Nadav Liam Modlin said the research had found that the drug enabled “powerful emotional breakthroughs” for patients and helped them develop “a sense of connection to themselves”. Some side effects of psilocybin, including headaches, nausea, dizziness, fatigue and suicidal ideation, were reported across all dose groups.
Researchers said only one patient had a “bad trip”, which was managed with sedatives. The psychedelic part of the experience lasted hours and occurred under supervision, after which patients were free to continue their business.
