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In November 2021, when psychedelic company Compass Pathways published the first effects of its psilocybin test on patients with treatment-resistant depression, the company’s stock fell nearly 30%. The drop was due to the somewhat poor effects of the research. but also through the dispersion of serious adverse occasions that happened in the trial. In the midst of the psychedelic renaissance, talking about its possible harm was somewhat taboo. The state, vilified for decades, has just returned to the mainstream, after all. Clinical trials are gaining momentum and drugs are increasingly commercialized, more likely to produce negative outcomes. With the effects of the Compass trial suggesting this, it is arguably time to open the discussion about the potential adverse effects of psychedelics, even if that means moderating the hype that has been piled up.
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These findings, now published in full in the New England Journal of Medicine, constitute the largest randomized, controlled, double-blind study ever conducted on psilocybin treatment. The participants, 233 of them, spread over 22 sites in 10 countries, were divided into 3 more or less equivalent organizations. One organization received 1 milligram of COMP360, Compass’s artificial psilocybin, a dose so low it served as a placebo. The next organization gained 10 mg and the last organization 25 mg. treatment.
The effects were promising, if they don’t represent the image of a miracle cure. In the 25 mg organization, 29% of patients were in remission after 3 weeks, compared with only 8% in the placebo organization. After some time, the positive effects faded: after 12 weeks, only 20% of patients who received high doses still responded, an improvement over placebo organization that is not statistically significant.
At the same time, 179 of the 233 patients in the trial reported at least one adverse event, such as headaches, nausea, fatigue or insomnia, uncomfortable, of course, but not of great concern. But 12 patients experienced serious adverse events. These have been explained as manifestations of suicidal ideation, adding self-harm. Five of the patients in the higher-dose organization reportedly exhibited suicidal behavior, as well as six in the 10 mg organization. This compared to only one in the placebo. organization.
“Is this planned in a rehearsal like this? To some extent, yes,” says Natalie Gukasyan, assistant professor and director of the Johns Hopkins Center for Psychedelic.
But given the general reluctance to live with the downsides of psychedelics, the fact that Compass reported adverse effects in advance is a smart move, says Joost Breeksema, a doctoral candidate who studies reports of psychedelic patients at the University Medical Center Groningen in the Netherlands. In August 2022, Breeksema published a review that looked at how adverse events were reported in psychedelic studies and found that they were inconsistent and, at most, likely unreported. Many trials reviewed through Breeksema reported no side effects, a minimal chance. Compass Pathways studies “reported adverse effects more rigorously than the maximum of the other trials in our systematic review,” he says.
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The explosion of enthusiasm around psychedelics could have influenced the adverse events of the trial. The growing popularity of those drugs has replaced people’s fundamental belief about them, which in turn can raise expectations ahead of a trial. This has been dubbed the Pollan effect by anthropologist Tehseen Noorani, in reference to the popular psychedelic e-book How to Change Your Mind, by publisher Michael Pollan. prepare new participants for their psychedelic sessions,” Noorani writes.
For those for whom psychedelics are a last hope, such as patients with treatment-resistant depression, when they have no effect it can be overwhelming and may only be part of the times of suicide. “You may believe that for someone who is already demoralized, that may be another stressor for them,” says Gukasyan. This potentially played a role in the serious adverse events in the trial: 3 of the patients in the 25mg organization who were suicidal did not respond to the drug, meaning their depression did not improve. “All 3 participating components did not respond to COMP360 psilocybin and had applicable histories of suicide or self-harm. This suggests that emerging suicidal tendencies are due to the treatment-resistant nature of depression, rather than the drug,” Guy Goodwin, lead medical director at Compass Pathways, told WIRED. Gukasyan also says that part of the challenge is the hype that has seen these compounds as wonder drugs. But as more knowledge is published, it is becoming clear that they are not, she says. “The treatment reaction rates go down once we start looking at larger samples. “
While adverse events are expected when working with a population as vulnerable as other people with treatment-resistant depression, there are still few studies on who is most at risk for them, how those events occur, and most importantly, how we take them. beware of events when they occur. ” If we’re talking about the 9 to 10 percent of other people who are going to have serious adverse events, it’s a question: How do we deal with this?”says Jules Evans, philosopher and member of Challenging Psychedelic Experiences, a study assignment that studies what is helping other people suffering after a trip.
This month, the organization released its first study, which collects testimonials from others who have had complicated reports about psychedelics and asks them what they found helpful and unnecessary to treat them. The first clinical study on psychedelics was published around 1880,” Evans says. “And there’s still no empirical knowledge about what’s helping other people who have negative psychedelic reports. “
A psychedelic adventure can be a difficult, even harrowing experience with positive therapeutic results, but infrequently with negative results. This shouldn’t slow down psychedelic research. about them, to find out how safe and useful those drugs can be. “It pays to be open, mature and curious about the dangers and the most productive way to deal with them,” Evans says. “And it’s worth doing now. “
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