This is the largest ever clinical trial of psilocybin in the treatment of depression.
The organizers of the trial announced on Tuesday (November 9th) that in the largest clinical trial of its kind to date, Xeloxibine is a hallucinogen found in the "magic mushroom", which helps to alleviate difficult-to-treat Symptoms in patients with depression.
Earlier this year, a small study showed that psilocybin may be as effective as the common antidepressant escitalopram (Lexapro) in relieving moderate to severe depression, and other past studies have also suggested this The future of drugs, Live Science previously reported. However, according to STAT, the new test conducted by the pharmaceutical company Compass Pathways is the largest psilocybin gold standard test so far, so its results may be more weighty than previous studies.
In other words, the results of the trial have not been peer-reviewed or published in journals, so further review of the data is necessary.
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The trial included 233 participants from 10 countries in North America and Europe. According to a statement from Compass Pathways, participants were divided into three groups, each of which received different doses of psilocybin "in combination with psychological support." Before the start of the trial, all participants had stopped taking antidepressants.
79 patients received a 25 mg dose of medication, 75 patients received a 10 mg dose, and 79 patients received a 1 mg dose. According to STAT, the lowest dose effectively acts as a placebo, which means it can be used as a comparison point for high-dose treatments. The trial is double-blind, which means that neither the trial organizer nor the participants know the therapeutic dose given to each patient.
Trial organizers used the Montgomery-Asperger Depression Scale (MADRS), a commonly used measure of clinical depression, to assess participants’ symptoms before and three weeks after treatment. The researchers found that by the third week, the score of the 25-mg dose group had dropped by an average of 6.6 points compared with the score of the low-dose group. However, the score of the 10 mg group was not significantly different from that of the low-dose group.
Related: 11 strange facts about "magic" mushrooms
Overall, by the third week, 29.1% of patients in the 25 mg dose group had entered remission, compared to only 7.6% in the placebo group. After three months of treatment, 24.1% of people in the 25 mg group still showed a "sustained response," which means their MADRS score dropped by at least half and remained at such a low level over time. According to the company's statement, by contrast, 10.1% of the placebo group showed a sustained response.
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During the trial, 12 participants experienced "serious adverse events" such as suicidal behavior, deliberate self-harm, or suicidal ideation. Of these participants, 5 were in the 25 mg group, 6 were in the 10 mg group, and 1 was in the 1 mg group. Guy Goodwin, head of Compass Pathways, said that the company's statement stated that these symptoms usually occur in people with treatment-resistant depression, and some suicidal behaviors occur in patients who have "essentially failed to respond" to treatment. According to STAT, medical staff.
STAT reports that because the number of people experiencing serious adverse events is very small, there is no statistically significant difference in the incidence of these adverse events between the three groups. But Compass Pathways plans to evaluate the data in more detail to see if there is a possible link between the dose of psilocybin and the likelihood of suicidal ideation.
Overall, the results of the trial are "very promising," although "we still lack a lot of detailed data," Boris Heifetz, a neuroscientist at Stanford University who studies psychedelics but was not involved in the study, told STAT.
In view of the strong results, Compass Pathways plans to advance the late-stage clinical trials of psilocybin, which may use a 25 mg dose, but the details still need to be discussed with the regulatory agency, co-founder and president Lars Christian Wilde. Compass Pathways, tell STAT. The most recent trial is the so-called Phase 2B trial, which aims to find the appropriate dose; the next trial, Phase 3, will test the selected dose in a larger group.
If you or someone you know needs help, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).
Read more about recent trials in STAT.
Originally published on Live Science.
Nicoletta Lanese is a full-time writer for Live Science, covering health and medicine, as well as various biological, animal, environmental and climate stories. She has a degree in neuroscience and dance from the University of Florida, and a graduate certificate in science communication from the University of California, Santa Cruz. Her work has appeared in media such as "Scientist Magazine", "Science News", "San Jose Mercury News" and Mongabay.
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