Approximately 100 million people in the world suffer from treatment-resistant depression, which means they have not responded to at least two antidepressant treatments for their major depressive disorder.
In a study from COMPASS Pathways and elsewhere, scientists found that a single 25 mg dose of COMP360 psilocybin, alongside psychological support, made a big impact in reducing symptoms of depression.
The team examined the change from baseline in the severity of depression in participants with treatment-resistant depression over the course of 12 weeks following a single dose of COMP360 psilocybin alongside psychological support.
The researchers found that participants reported a greater reduction in depression scores three weeks after taking a single 25 mg dose of COMP360 psilocybin compared to those who took the lowest 1 mg dose.
Some adverse effects, such as headaches, nausea, dizziness, fatigue, and thoughts around suicide, were reported across all dose groups.
This clinical trial was conducted at 22 sites in 10 countries across Europe (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.
In the study, 233 participants with treatment-resistant depression were allocated at random to receive a single 25 mg, 10 mg, or 1 mg dose of COMP360 psilocybin, along with psychological support; with those who received the 1 mg dose acting as a control group.
Neither the participants nor the researchers were aware of which dose the participant had received.
This study is the largest clinical trial on the use of psilocybin for treatment-resistant depression to date, and it demonstrated that a single 25 mg dose of psilocybin improved participants’ symptoms of depression in comparison to a 1 mg dose (control).
The team’s task now is to investigate psilocybin for treatment-resistant depression in larger clinical trials with more participants, comparing it both to placebo and to established treatments.
For more information about nutrition, please see recent studies that ultra-processed foods may make you feel depressed, and antioxidants that could help reduce the risk of dementia.
The study was conducted by Dr. James Rucker et al and published in the New England Journal of Medicine.
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