A single dose of a synthetic version of the mind-altering compound found in magic mushrooms, the psilocybinhas shown its effectiveness in treating depression in people with treatment resistance.
The results are from a randomized, double-blind clinical trial, published in “The New England Journal of Medicine”, and which its authors consider “the largest of its kind”, and show “an immediate, rapid and fast-acting sustained response to 25 milligrams of the compound”, emphasizes the author of the study, Guy Goodwin, of the University of Oxford (United Kingdom).
Although the drug can be extracted from magic mushrooms, Goodwin clarifies that this has not been the way in which this compound has been manufactured, but that it has been synthesized in a purely chemical processor to produce a crystalline form.
Experts found the findings promising
However, there are a number of issues that need further study before this drug is available for clinical use, the researchers acknowledge.
The 25mg psilocybin drug puts patients in a dreamlike state, making psychological therapy more likely to succeed. But short-term side effects can be frightening, and support should always be available, the researchers warn.
For example: the effects began to wear off at three months and although the safety profile seems encouraging overall, great care is needed when using psychoactive substances such as psilocybin.
Short-term side effects can be frightening, and support should always be available, researchers warn
The clinical trial was carried out in the USA, Canada and 8 European countries (Czech Republic, Denmark, Germany, Ireland, the Netherlands, Portugal, spain and UK). The study was designed to test the safety of different doses of the proprietary version of psilocybin.
All 233 study participants had treatment-resistant depression, which can only be diagnosed after a person fails to respond to two cycles of antidepressants. Worldwide, about 100 million people have treatment-resistant depression.
These people are at high risk for physical illness, disability, hospitalization and suicide, according to the study.
About 100 million people have treatment-resistant depression in the world
All participants taking antidepressants were asked to wean themselves off those medications before the start of the trial. Psychedelic treatment doesn’t work in people who are actively taking antidepressants: the receptors that psychedelics attach to in the brain are already flooded with serotonin from your current mood-altering drugs.
The patients, lying on a bed in a quiet room, experienced a psychedelic “trip,” which one described as “a waking dream,” for six to eight hours.
A therapist was available to provide support.
The next day and a week later, the patients received psychological support to tell about their experience.
Patients, lying on a bed in a quiet room, experienced a psychedelic “trip”
Depression levels were documented the day after the “trip” and five other times over a 12-week period. About 37% of people taking the 25-milligram dose showed improvement. In fact, 29% were considered to be in remission at week 3.
However, by week 12, the positive impact on depressive symptoms had diminished and no longer reached a level of statistical significance.
“The incidence of sustained response at week 12 was 20% in the 25mg group, 5% in the 10mg group, and 10% in the 1mg group,” he writes. Bertha Madrasof McLean Hospital, Harvard Medical School, USA, in an accompanying editorial, and who was not involved in the study.
Headache, nausea, fatigue, and dizziness affected 77% of study participants and occurred at all dose levels, which experts say is a typical response on the day of psilocybin administration.
A small number of people in all three dose groups experienced suicidal thoughts or were injured during the 12-week follow-up period, the study found.
Those behaviors are “common in studies of treatment-resistant depression: most cases occurred more than a week after the psilocybin session.” COMP360», noted the researchers.
A larger trial is scheduled to begin to study how many doses are needed to prevent depression from coming back.
Now, it could be three years before the drug is close to being licensed, the researchers add.