FDA Puts ‘Magic Mushroom’ Ingredient on Fast Track for Depression Treatment
Company will soon begin clinical trials to determine how effective psilocybin is in treating depression.
Researchers are on a fast track to developing a treatment for depression using the psychedelic compound psilocybin, best known as the active ingredient in so-called “magic mushrooms.”
That means an accelerated research and approval process for a drug with strong preliminary evidence showing it would be a substantial improvement over currently available therapies.
“The early studies have shown that psilocybin therapy can provide an immediate and sustained reduction in depression following a single treatment,” Tracy Cheung, communications director for COMPASS Pathways, told Healthline. “The effect has been described as psilocybin shaking the brain up like a snow globe, or rebooting the brain, providing new connections and deactivating connections that might have caused depression.”
COMPASS Pathways is running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression.
The study will take place in Europe and North America over the next year or so.
“The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible,” said George Goldsmith, COMPASS Pathways chairman and co-founder, in a statement.
The 400-plus patients enrolled in the study will receive synthesized psilocybin capsules, not mushrooms.
The clinical trial will take 12 to 18 months to complete.
The life sciences company is working with the Heffter Research Institute, which funded the first research into using psilocybin to treat depression at Johns Hopkins University, New York University, and the University of California Los Angeles (UCLA).
The potential magic in mushrooms
Last year, researchers at Imperial College London reported that patients with treatment-resistant depression saw improvements for up to five weeks after taking psilocybin.
In that study, 19 patients were given two doses of psilocybin. They also received psychological support.
Brain scans found reduced blood flow to areas of the brain associated with emotional processing as well as stress and fear. There was also more stability in a part of the brain associated with depression.
Psilocybin isn’t the first drug known primarily for its abuse potential to be examined for its therapeutic potential.
This year, the FDA approved Epidiolex, derived from cannabis, as a treatment for epilepsy.
FDA approval also is being sought for esketamine, a depression drug based on the oft-abused sedative ketamine, which induces a trance-like state in users.
Robin Carhart-Harris, head of the Psychedelic Research Group at Imperial College London, called the breakthrough therapy designation “a strong endorsement for the potential of psilocybin therapy.”
In an interview at the 2018 American Society of Clinical Psychopharmacology annual meeting, Carhart-Harris said that like SSRIs, the most common class of anti-depression drugs, psilocybin acts on the brain’s serotonin system, specifically the serotonin 2A receptor.
“You take a globe that’s got those little snow bits… and it’s settled. The snow is all at the bottom. Say you pick it up, you shake it, and there’s disorder there. But then the snow will settle again,” he said. “And this is this principle of a re-setting or re-configurating the brain, and it’s an analogy that’s being used traditionally in the context of electroconvulsive therapy, but it’s also being used now in the context of some of the novel treatments that are being explored for, say, treatment-resistant depression, the likes of ketamine.”
“The notion is that you take a system that’s become entrenched in pathology. It’s fallen into a pattern or patterns that aren’t healthy, and those patterns have become reinforced for whatever reasons,” added Carhart-Harris. “And so you can introduce psychedelics and you can shake things up, and you can work on revising or updating some of those patterns and likely the beliefs which they relate to and so essentially revise your belief structure.”
Searching for better treatments
Dr. Kenneth Duckworth, a Harvard University professor and medical director of the National Alliance on Mental Illness (NAMI), told Healthline there are relatively few new depression medications in the pipeline.
“We need to look more creatively for medications to treat depression and welcome thoughtful research on drugs that might be considered nontraditional,” said Duckworth. “Look at the suicide rate in this country. We have a deep need for better treatment.”
Duckworth said researchers don’t really fully understand why drugs such as psilocybin and ketamine seem to ease depression, but noted that the same is true for many other mental health drugs, including the classic treatment for bipolar disorder, lithium.
“What we do observe is that it works,” he said.
Study subjects selected for tests involving psychedelic drugs such as psilocybin should be carefully screened for elevated risk of psychotic episodes, including personal and family history, said Duckworth.
Despite concerns about “bad trips,” Duckworth said these medications should be considered.
“My experience with people who have treatment-resistant depression is that they might be open to novel treatments,” he said.