Something unexpected happened when, early in 2017, Roland Griffiths and Stephen Ross brought the results of their clinical trials to the FDA, hoping to win approval for a larger, phase 3 trial of psilocybin for cancer patients. Impressed by their data—and seemingly undeterred by the unique challenges posed by psychedelic research, such as the problem of blinding, the combining of therapy and medicine, and the fact that the drug in question is still illegal—the FDA staff surprised the researchers by asking them to expand their focus and ambition: to test whether psilocybin could be used to treat the much larger and more pressing problem of depression in the general population.
As the regulators saw it, the data contained a strong enough “signal” that psilocybin could relieve depression; it would be a shame not to test the proposition, given the enormity of the need and the limitations of the therapies now available. Ross and Griffiths had focused on cancer patients because they thought it would be easier to win approval to study a controlled substance in people who were already seriously ill or dying. Now the government was telling them to raise their sights. “It was surreal,” Ross told me, twice, as he recounted the meeting, still somewhat stunned at the response and outcome. (The FDA declined to confirm or deny this account of the meeting, explaining that it doesn’t comment on drugs in development or under regulatory review.)
Much the same thing happened in Europe, when, in 2016, researchers approached the European Medicines Agency (EMA)—the European Union’s drug-regulating body—seeking approval to use psilocybin in the treatment of anxiety and depression in patients with life-changing diagnoses. “Existential distress” is not an official DSM diagnosis, the regulators pointed out, so the national health services won’t cover it. But there’s a signal here that psilocybin could be useful in treating depression, so why don’t you do a big, multisite trial for that?
The EMA was responding not only to the Hopkins and NYU data but also to the small “feasibility study” of the potential of using psilocybin to treat depression that Robin Carhart-Harris had directed in David Nutt’s lab at Imperial College. In the study, the initial results of which appeared in Lancet Psychiatry in 2016, researchers gave psilocybin to six men and six women suffering from “treatment-resistant depression”—meaning they had already tried at least two treatments without success. There was no control group, so everyone knew he or she was getting psilocybin.
After a week, all of the volunteers showed improvement in their symptoms, and two-thirds of them were depression-free, in some cases for the first time in years. Seven of the twelve volunteers still showed substantial benefit after three months. The study was expanded to include a total of twenty volunteers; after six months, six remained in remission, while the others had relapsed to one degree or another, suggesting the treatment might need to be repeated. The study was modest in scale and not randomized, but it demonstrated that psilocybin was well tolerated in this population, with no adverse events, and most of the subjects had seen benefits that were marked and rapid.*
The EMA was sufficiently impressed with the data to suggest a much larger trial for treatment-resistant depression, which afflicts more than 800,000 people in Europe. (This is out of a total of some 40 million Europeans with depressive disorders, according to the World Health Organization.) Rosalind Watts was a young clinical psychologist working for the National Health Service when she read an article about psychedelic therapy in the New Yorker.
The idea that you might actually be able to cure mental illness rather than just manage its symptoms inspired her to write to Robin Carhart-Harris, who hired her to help out with the depression study, the lab’s first foray into clinical research. Watts guided several sessions and then conducted qualitative interviews with all of the volunteers six months after their treatments, hoping to understand exactly how the psychedelic session had affected them.
Watts’s interviews uncovered two “master” themes. The first was that the volunteers depicted their depression foremost as a state of “disconnection,” whether from other people, their earlier selves, their senses and feelings, their core beliefs and spiritual values, or nature. Several referred to living in “a mental prison,” others to being “stuck” in endless circles of rumination they likened to mental “grid-lock.” I was reminded of Carhart-Harris’s hypothesis that depression might be the result of an overactive default mode network—the site in the brain where rumination appears to take place. The Imperial depressives also felt disconnected from their senses. “I would look at orchids,” one told Watts, “and intellectually understand that there was beauty, but not experience it.”
Source : VICE
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