People with depression do not always respond to available therapies; in fact, it is estimated that there are about 100 million people who suffer from treatment-resistant depression, that is, who have not responded to at least two antidepressant treatments. Therefore, the results of the largest clinical trial to date may open a door of hope for those affected, as they have revealed that administering a single dose of 25 mg of psilocybin, together with supportive psychotherapy, has had a significant impact. in reducing the severity of depressive symptoms in patients with treatment-resistant depression.
Psilocybin is a psychoactive substance contained in hallucinogenic mushrooms, and it is not the first time that it has been linked to relieving symptoms of depression, as a study conducted by scientists at the Johns Hopkins School of Medicine in 2020 found that Administering it together with supportive psychotherapy, the majority of the participants experienced an improvement in their major depressive disorder.
This phase 2b clinical trial is the largest to date to test the effects of psilocybin in reducing symptoms of depression and has been conducted by COMPASS Pathways in 22 international centers in 10 European countries (Republic Czech Republic, Denmark, Germany, Ireland, the Netherlands, Portugal, Spain and the United Kingdom) and North America (Canada and the United States) between March 1, 2019 and September 27, 2021, including the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London and South London and the Maudsley NHS Foundation Trust. Their results have been published in the New England Journal of Medicine.
Efficacy of psilocybin in treatment resistant depression
The researchers studied how symptom severity varied in 233 participants with treatment-resistant depression over 12 weeks after receiving a single dose of psilocybin COMP360, along with psychological support. The participants were divided into two groups to receive a single dose of 25 mg, 10 mg, or 1 mg of psilocybin; the latter acted as a control group, and neither the participants nor the researchers knew the dose administered to each participant.
“Psilocybin COMP360 has a true pharmacological effect, a finding that is critical for it to be recognized as a new treatment option for depression in the future”
The day before psilocybin administration, the severity of depressive symptoms was assessed, and follow-up interviews were conducted on days two and weeks one, three, six, nine, and 12. Participants received the substance in rooms with a calm environment and the psychedelic effects lasted between six and eight hours, during which time a therapist remained in the room to provide psychological support. After the psychedelic effects wore off, the participants returned home.
The researchers found that participants who received the 25-mg dose of psilocybin experienced a greater reduction in depression scores than those who received the 1-mg control dose. There were no significant differences in changes in depression between those who received the 10 mg and 1 mg dose and between those who received the 25 mg and 10 mg dose.
During the 12 weeks that the study lasted, 84% of the participants in the 25 mg group experienced adverse effects, such as headache, nausea and dizziness, which also affected 75% of the individuals in the 10 mg group and 72% of those included in the 1 mg group. Suicidal ideation and intentional self-harm were observed in all dose groups, as is common in studies of treatment-resistant depression. Most of the cases occurred more than a week after the psilocybin session. There was no mean worsening of suicidal ideation scores on the Depression Rating Scale in any dose group.
Dr James Rucker, Co-Director of the Psychoactive Trials Group at King’s IoPPN and Consultant Psychiatrist at South London and Maudsley NHS Foundation Trust, said: “While many patients with mental health problems do improve with available treatments, a subgroup of people It doesn’t, even though they try.” Therefore, “new treatment paradigms are needed and clinical investigation of new treatments is important. Psilocybin therapy may be a new treatment paradigm, but this needs to be tested in clinical trials. We are doing this work in the Psychoactive Trials Group, providing new and pioneering treatments in collaboration with our colleagues at the Maudsley Center for Advanced Treatments.”
“The publication of our COMP360 psilocybin therapy study in the world’s most prestigious peer-reviewed medical journal is a proud moment for everyone involved,” said Dr. Guy Goodwin, Medical Director of COMPASS Pathways. “We saw positive results in a particularly difficult group of patients to treat, and the highest dose of psilocybin COMP360 had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be 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 COMP360 psilocybin with psychological support to patients who desperately need it.”
For his part, Dr. Eduard Vieta, Scientific Director of the Center for Biomedical Research in the Mental Health Network (CIBERSAM), Head of the Psychiatry and Psychology Service at Hospital Clínic de Barcelona and professor at the University of Barcelona, told SMC Spain: “This is a high-quality study, which shows that the combination of a substance with properties to mimic the action of serotonin, a brain neurotransmitter, can significantly improve depression with a single dose, associated with a brief psychotherapy. The drug in question is a synthetic variant of a substance contained in certain mushrooms with hallucinogenic properties and was therefore administered in a highly controlled environment. This is still a preliminary study, but if its results are reproduced in a larger study, we could be talking about a revolutionary change in the treatment of those forms of depression that do not respond to the usual treatments. It should also be noted the good tolerability of this substance. They are, in short, good news but they should still be taken with caution.
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