For the past few years, scientists have been studying how psilocybin, the psychedelic compound in magic mushrooms, can relieve symptoms of depression.
More evidence of the link has arrived with a double-blind phase 2 trial involving 233 participants, the largest study on this topic to date in terms of sample size.
The volunteers all had treatment-resistant depression, meaning that at least two antidepressant treatments failed to relieve major depressive disorder.
Led by mental health care company COMPASS Pathways, the clinical trials lasted 12 weeks and were conducted at 22 sites in 10 different countries in Europe and North America.
For the purposes of the study, the participants were divided into three groups. One group received a single 25mg dose of a synthetic form of psilocybin called COMP360, modeled after the psychedelic compound found in magic mushrooms, a second group received 10mg, and the final group (acting as a control) received 1 mg. None of the volunteers knew what dose they had received.
“This study, which is by far the largest clinical trial of the use of psilocybin for treatment-resistant depression to date, demonstrated that a single dose of 25 mg of psilocybin reduced the severity of participants’ symptoms by compared to a control dose of 1 mg,” says psychiatrist James Rucker, from King’s College London in the UK.
However, there was no substantial difference between the 10 mg group and the 1 mg group.
It wasn’t all good news, however. In the 25mg group, 84% of volunteers reported side effects such as headache, nausea, and dizziness within three months of taking the drug, while a handful experienced more serious side effects. , two of whom reported self-harm and two suicidal. ideation.
Fewer participants in the other two groups reported having similar experiences, with around three-quarters of each also describing the least severe effects. Only one percent of those taking 1mg of COMP360 experienced the most severe side effects.
The researchers note that future studies need to be vigilant in light of the side effects, but are confident that the subjects’ progress has been positive.
Psilocybin was administered in dedicated rooms designed to put participants at ease, and a therapist was present until the psychedelic effects wore off and the individuals were allowed to leave (which took between six and eight hours).
Over the following weeks, the Montgomery-Åsberg Depression Rating Scale was used to assess any changes in symptoms of depression in those involved in the trial. The questions used by the scale relate to mood, blood pressure, sleep and appetite.
“These results are a positive step in the right direction,” says Rucker. “Our task now is to study psilocybin for treatment-resistant depression in larger trials with more participants, comparing it to both placebo and established treatments.”
The researchers are now ready to move on to a phase 3 trial, where psilocybin will be compared to the best treatments currently available for depression. That should tell us more about whether this magic mushroom compound is ready for widespread use.
Researchers suspect that psilocybin’s hallucinogenic properties alter brain connectivity in some way, although it’s still unclear exactly how this happens. Previous studies have also shown that the compound psilocybin may be effective in treating alcohol addiction.
Another added benefit of this study was the opportunity to improve the way psilocybin treatments are delivered to patients, with guidelines developed for therapists to help them manage initial hallucinations and other effects of the drug. .
“As part of the training programme, a therapy manual has been developed to enable standardization of psychological support between sites and therapists around the world,” says psychologist Nadav Liam Modlin, of King’s College London.
The research was published in the New England Journal of Medicine.
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