Severe depression eased with synthetic ‘magic mushroom’
A single dose of a synthetic version of the mind-altering ingredient psilocybin in magic mushrooms improves depression in people with a treatment-resistant form of the disease, a new study has found.
The randomized, double-blind clinical trial, which the authors called “the largest of its kind,” compared the results of a 25-milligram dose with 10-milligram and 1-milligram doses of the synthetic psilocybin COMP360 administered in the presence of trained therapists;
Study results, published Wednesday in The New England Journal of Medicinefound “an immediate, rapid, fast-acting, sustained response to 25 milligrams (COMP360),” said study co-author Dr. Guy Goodwin, professor emeritus of psychiatry at the University of Oxford in the United Kingdom.
“This potion can be extracted with a magic mushroom, but that’s not how our compound is produced. It’s synthesized through a purely chemical process to get a crystalline form,” said Goodwin, who is chief medical officer at COMPASS Pathways, the company that makes COMP360 and conducted the research.
Experts in the field considered the research results promising.
“They clearly found a dose effect and clinically meaningful improvement in just three weeks,” said Dr. Matthew Johnson, professor of psychology and mindfulness at Johns Hopkins Medicine in Baltimore. He was not involved in the new study.
“If you’re in the 25-milligram group, you’re almost three times more likely to respond than if you’re in the 1-milligram group,” said Johnson, who In 2008, he co-authored the Guidelines for the Safety of Psychiatric Research.
The rapid response to the treatment was also remarkable.
“The maximum effect (was observed) the day after receiving the treatment. This is in contrast to standard antidepressants, which take several weeks to reach their maximum effect,” said Dr Anthony Clare, Professor of Psychopharmacology and Affective Disorders at King’s College London. He was not involved in the study.
However, there are a number of issues that need further study before this drug is available for clinical use, experts say.
“The effects started to wear off after three months, and we need to know how best to prevent the depression from returning,” Clare said, adding that not enough is known about possible side effects.
“While the overall safety profile appears encouraging, great care is clearly needed when using psychoactive substances such as psilocybin. Larger studies are on the way that we hope will help answer these questions,” he said.
The clinical trial was conducted at 22 sites in seven countries in the US, Canada, the UK and Europe. The study was designed to test the safety of different doses of a specific version of psilocybin.
The 233 study participants had treatment-resistant depression, which can only be diagnosed after a person fails to respond to two courses of antidepressants. Of the 9 million people in the US with medical depression, 3 million are resistant to treatment. studies have assessed. About 100 million people worldwide have treatment-resistant depression, Goodwin said.
People with the condition are at increased risk of physical illness, disability, hospitalization and suicide, the study found.
Any study participant Antidepressants were required to be off these medications before the start of the trial. Psychiatric treatment does not work for people who are actively taking antidepressants. the receptors in the brain that psychedelics attach to are already flooded with serotonin from their current mood-altering drugs.
“Participants were asked to stop antidepressant treatment within the first 3 weeks after taking the trial drug; However, these medications may be started at any time during the trial if deemed clinically necessary by the physician investigator,” the study said.
Severity of depression was assessed for each person the day before treatment using a psychological scale widely used by the clinic. Counselors trained to offer psychological support were present during the psychiatric trips, which lasted six to eight hours. During the first week, participants were given two more therapies, the study said.
Depression levels were recorded the day after the “trip” and five more times over a 12-week period. About 37% of people who took the 25-milligram dose improved. In fact, 29% were considered in remission by week three, the study found.
However, by week 12, the positive effect on depressive symptoms had weakened and no longer reached the level of statistical significance, the study found.
“The incidence of sustained response at week 12 was 20% in the 25 mg group, 5% in the 10 mg group, and 10% in the 1 mg group,” wrote psychobiologist Dr. Bertha Madras, director of the Addiction Neurobiology Laboratory at Harvard Medical School’s McLean Hospital in Belmont, Massachusetts. in the attached editorial. He did not participate in the study.
“This no an impressive response rate to psychiatric treatment … and we only expect it to worsen over a longer follow-up period,” said: Dr Ravi Das is Associate Professor of Research Methods and Statistics in Educational Psychology, University College London via email. One who was not involved with the study.
In addition, “there were unequal numbers of severely depressed patients in each group; with significantly less severe depression in the apparently ‘effective’ (25 mg) dose group,” Das said in a statement. “It doesn’t seem to get in the paper.”
Headache, nausea, fatigue, and dizziness were experienced by 77% of study participants and occurred at all dosage levels, which experts say is a typical response to psilocybin on the day.
The study found that a small number of people in all three dose groups experienced suicidal thoughts or harmed themselves during their 12-week follow-up period. In the first three weeks alone, two people in the 25-milligram group thought about suicide, and two intentionally hurt themselves. In the 10-milligram group, two people committed suicide, one self-harmed, and one was hospitalized for severe depression, the study said.
Those behaviors are “common in studies of treatment-resistant depression; most cases occurred more than one week after a COMP360 psilocybin session,” the company says.
“Remember, this is in people who were assessed as being at significant risk of suicide when they entered the trial. The numbers were quite small, but this is something that should be carefully considered in future phase trials,” said Kevin McConway, emeritus professor of applied statistics at The Open University, a British public research university.
The results of the study are promising, but many questions remain, and it is unknown whether this drug will be successful in different types of depression, said McConway, who was not involved in the study.
“They can’t tell us how effective this psilocybin plus therapy treatment is compared to other existing drug or non-drug treatments for depression,” McConway said, noting that as the next step for further trials.
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