The psychedelic found in magic mushrooms can help relieve major depression when combined with psychotherapy.
Nearly a third of patients with major depression went into rapid remission after a single dose of 25 mg psilocybin followed by therapy sessions, which aimed to help patients identify the causes and possible solutions to their depression, researchers said.
The results of the largest clinical study to date on psilocybin and depression were described as "exceptional" by Prof Guy Goodwin, the chief medical officer at Compass Pathways, the mental health company that led the trial, which was conducted at 22 sites in the United States. UK, Europe and America.
Therapy-resistant depression
Worldwide, an estimated 100 million people have treatment-resistant depression, defined as a major depressive disorder that has not responded to at least two antidepressant treatments. About half of those affected are unable to perform routine daily tasks.
"The response rates in this group with treatment-resistant depression are usually between 10 and 20%," Goodwin said. "We're seeing remission rates after three weeks of about 30%...that's a very satisfying result."
dr. James Rucker, a psychiatrist in South London and Maudsley NHS Foundation Trust, who participated in the study at King's College London, said treatment-resistant depression placed a "staggering" burden on patients and those around them, with a total cost to the UK of £3,9, XNUMX billion a year.
The Phase 2b clinical trial recruited 233 patients with drug-resistant depression and randomly assigned them to a single 1 mg, 10 mg or 25 mg capsule of synthetic psilocybin called Comp360. Patients listened to a calming playlist and wore sleep masks to focus their attention inward for at least six hours. A therapist was present to monitor the patients. The volunteers had therapy sessions the day after they received the drug and a week later.
Results published in the New England Journal of Medicine show that depression scores, measured on the standard Montgomery-Åsberg depression scale, improved immediately after treatment in all three arms of the study.
The most significant impact was in those who received the highest dose of psilocybin of 25 mg. Three weeks after taking the drug, 29% of this group was in remission, compared with 9% and 8% of the 10 mg and 1 mg groups, respectively. After 12 weeks, benefits persisted in one-fifth of those in the high-dose group, compared with one in 10 in the lowest-dose group.
Psilocybin as medicine
Psilocybin is the main active ingredient in magic mushrooms. In the body, it is broken down into a substance called psilocin, which releases waves of neurotransmitters in the brain. MRI scans show that brain activity becomes more chaotic due to psilocin, with different brain regions talking to each other more than usual. "That may seem like a bad thing, but it isn't," Rucker said. “That happens every night: when you dream, your brain becomes more plastic, slightly more chaotic, new connections are formed.”
Patients in the study said that they were in a dream because of psilocybin, but were still awake. The increased connectivity in the brain appears to have a longer-lasting effect, but lasts for several weeks and makes the brain more receptive to therapy. "When the brain is in a more flexible state, it opens up what we consider to be a therapeutic opportunity," Rucker said.
David Nutt, a professor of neuropsychopharmacology at Imperial College London who was not involved in the study, said the rapid effect of psilocybin suggested it disrupted negative cycles in the patients, effectively acting as a "reset" for the brain.
Despite the obvious benefits, many patients reported side effects in the study, the most common of which were headache, nausea, dizziness, and fatigue. One person had a bad trip and was given a sedative to reduce anxiety. As is common in treatment-resistant depression, a number of patients in various branches of the study reported self-harm and suicidal ideation.
Suicidal behavior was seen in three patients who failed to respond to the 25 mg dose of psilocybin at least one month after taking the drug. According to Nutt, these cases were likely random events and unrelated to the psilocybin dose. A larger phase 3 study that will examine the effects of two doses of psilocybin is due to start later this year.
Source: theguardian.com (EN)
