by Psilocybin, the active ingredient in magic mushrooms, could reduce symptoms in people with treatment-resistant depression, research suggests.
It is estimated that around 100 million people worldwide suffer from this condition, which means that they have not responded to at least two antidepressant treatments for their major depressive disorder.
The study of 233 people suggests that three weeks after people received a single 25mg dose of psilocybin, they had lower levels of depressive symptoms than people on lower doses (1mg or 10mg).
The psilocybin in the study – called COMP360 – was not derived from magic mushrooms, but was instead created with a purely chemical process.
People were treated in specialized rooms designed to provide a non-clinical and relaxing atmosphere.
Researchers say some have reported a “dreamlike” state.
The psychedelic effects lasted between six and eight hours and during this time an experienced therapist was in the room to provide psychological support.
All therapists underwent a detailed training program designed for experimentation.
After the psychedelic effects were completely dissipated, the participants were able to go home.
Dr James Rucker, a consultant psychiatrist and head of the Psychoactive Trials Group at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust, took part in the research.
He said: “While many patients with mental health problems improve with the treatments available, a subset of patients do not even if they try many different forms of treatment.
“This is sometimes called ‘treatment resistance’. This can lead to a number of other problems that have a serious impact on patients and the people around them.
“Treatment options are often limited, with bothersome side effects and / or stigma.
“Therefore, new treatment paradigms are needed and the clinical search for new treatments is important.
“Psilocybin therapy may be a new treatment paradigm, but this needs to be tested in clinical trials.”
The study, published in the New England Journal of Medicine, investigated the change in depression severity in people with treatment-resistant depression for 12 weeks after a single dose of psilocybin COMP360.
The researchers found that people reported a greater reduction in depression scores three weeks after taking a single 25 mg dose of psilocybin COMP360 than those who took the lower 1 mg dose.
Some adverse effects, such as headache, nausea, dizziness, fatigue, and thoughts of suicide, were reported in all dose groups.
Professor Guy Goodwin, COMPASS Pathways chief medical officer, said, “We have seen positive results in a particularly difficult-to-treat group of patients and the higher dose of psilocybin COMP360 had the greatest impact on people’s depression.
“This suggests that psilocybin COMP360 has a true pharmacological effect, a finding that is key to being recognized as a new treatment option in the future.
“We look forward to starting our Phase 3 program later this year, moving closer to providing psilocybin COMP360 with psychological support for patients in dire need.”
According to the study, suicidal ideation and intentional self-harm were observed in all dose groups, as is common in treatment-resistant depression studies.
Most cases occurred more than a week after the COMP360 psilocybin session.
There was no mean worsening of suicidal ideation scores on the scale used in any dose group.
Suicidal behavior was reported at least one month after COMP360 administration for three non-responders in the 25 mg group.
The Phase 2b clinical trial was conducted at 22 sites in 10 countries in Europe (Czech Republic, Denmark, Germany, Ireland, the Netherlands, Portugal, Spain and the United Kingdom) and in North America (Canada and the United States) between 1 ° March 2019 and 27 September 2021.
The study, designed and funded by COMPASS Pathways, was conducted in collaboration with the Psychoactive Trials Group at the IoPPN and the South London and Maudsley NHS Foundation Trust.
Professor Andrew MacIntosh, head of the division of psychiatry at the University of Edinburgh and a member of the MQ Mental Health Research Science Council, said: “This new study greatly improves our understanding that psilocybin can potentially help depressed people when conventional treatments have failed. “
He added: “It is the strongest evidence to date to suggest that further, larger and longer randomized trials of psychedelics are warranted and that psilocybin could (someday) provide a potential alternative to antidepressants that have been prescribed for decades.”
Anthony Cleare, professor of psychopharmacology at King’s College London, said: “This is the largest study to date on the use of psilocybin for treatment-resistant depression.
“Given that the patients had not responded to between two and four other treatments, it is a very encouraging finding that nearly four out of 10 showed a clear response to a single dose of psilocybin.
“It is also noteworthy how quickly the effects of the treatment began, with the maximum effect observed the day after receiving the treatment.
“This contrasts with standard antidepressants, which take several weeks to achieve maximum effect.”
