The psychedelic compound found in magic mushrooms, when combined with psychotherapy, may help relieve major depression, according to a study raising hope for people failing on existing antidepressants.
Almost a third of patients with major depression went into rapid remission after a single dose of 25 mg of psilocybin followed by therapy sessions aimed at helping patients identify causes and possible solutions to their depression, the researchers said.
The results of the largest clinical trial to date on psilocybin and depression were described as “ extraordinary” described America.
An estimated 100 million people worldwide have treatment-resistant depression, defined as major depressive disorder that has failed to respond to at least two treatments with antidepressants. About half of those affected are unable to carry out everyday tasks.
“Response rates in this group with treatment-resistant depression are typically between 10% and 20%,” Goodwin said. “We’re seeing remission rates of about 30% at three weeks…that’s a very satisfying result.”
dr James Rucker, a consultant psychiatrist at the South London and Maudsley NHS Foundation Trust who worked on the study at King’s College London, said treatment-resistant depression is an “astonishing” burden on patients and those around them, with a total cost to the UK of 3, £9 billion a year.
The phase 2b clinical trial recruited 233 patients with resistant depression and randomly assigned them to a single capsule containing either 1 mg, 10 mg, or 25 mg of synthetic psilocybin called Comp360. Patients listened to a calming playlist and wore eye shields to draw their attention inward for at least six hours while the psychedelic took hold.
A therapist was present at all times to ensure patients were safe and well. The volunteers did therapy sessions the day after taking the drug and a week later.
The 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 study arms.
The most significant effect was in those receiving the highest 25 mg dose of psilocybin. Three weeks after taking the drug, 29% of this group were in remission, compared to 9% and 8% of the 10 mg and 1 mg groups, respectively. After 12 weeks, the benefit persisted in one-fifth of patients in the high-dose group, compared with one in 10 in the lowest-dose group.
Psilocybin is the main active ingredient in magic mushrooms. In the body, it breaks down into a substance called psilocin, which releases waves of neurotransmitters in the brain. MRI scans show that brain activity becomes more chaotic on psilocin, with different regions of the brain talking to each other more than usual.
“That might seem like a bad thing, but it’s not,” Rucker said. “This happens every night: when you dream, your brain becomes more plastic, a little more chaotic, and then new connections are made.”
Patients in the study spoke of being in a “waking dream” while taking psilocybin, a short-lived experience that wore off before they returned home. However, the increased connectivity in the brain appears to be a more permanent effect, lasting a few weeks and potentially making the brain more open to therapy.
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“When the brain is in a more flexible state, what we think of as a therapeutic time window opens up,” Rucker said.
David Nutt, a professor of neuropsychopharmacology at Imperial College London, who was not involved in the study, said psilocybin’s rapid action suggested it was breaking negative cycles of rumination in patients and actually acting as a “reboot” for the brain .
Despite the obvious benefits, many patients in the study reported side effects, the most common being headaches, nausea, dizziness, and fatigue. One person had a bad trip and was given a sedative to relieve their anxiety. As is common in treatment-resistant depression, some patients in different study arms reported self-harm and suicidal thoughts.
Suicidal behaviors were observed in three patients who failed to respond to the 25 mg dose of psilocybin for at least a month after taking the drug.
According to Nutt, these cases were likely random events and unrelated to the dose of psilocybin that would have been completely removed from the patient’s body. A larger phase 3 trial, which will examine the effects of two doses of psilocybin, is scheduled to begin later this year.