A new study investigates the effects of psilocybin, also known as psilocybin, on severe depression,media New Atlas reported. This randomized clinical trial has found that psilocybin-assisted therapy is effective in producing large, rapid and persistent antidepressant effects in patients with severe depression. A larger Phase 2 trial is currently under way.
The U.S. Food and Drug Administration (FDA) has twice in the past 24 months awarded the title of psilocybin breakthrough therapy, the main psychoactive compound in “magic mushrooms.” The title was originally awarded to help speed up trials of severe drug-resistant depression, but more recently, the classification has focused on trials of severe depression.
In the past few years, promising preliminary studies have shown that psilocybin may be effective in helping patients with advanced cancer manage end-of-life anxiety. The initial psilocybin trial focused on depression, particularly the treatment of drug-resistant depression — a clinical classification that classifys patients with depression who do not respond effectively to at least two different medications for antidepressants during the current onset of depression.
Depression is more common, with some estimates suggesting that more than 300 million people worldwide have the condition. While a larger Phase 2 trial to test psilocybin for depression is currently under way, the new study, published in the Journal of Psychiatry of the American Medical Association, provides the first peer-reviewed data to show the efficacy of this particular mental health condition.
The small preliminary trial recruited 24 subjects with at least two years of history of depression. All subjects must abstive from any antidepressant treatment before the trial begins.
Use the standard GRID-Hamilton depression score sheet to assess depression. Severe depression was rated 24 points or higher on the scale, while 7 points or less were classified as depression-free. At the start of the study, the average score for the queue was 23. The treatment process is similar to the general procedure used in most psilocybin studies. Each subject was given two doses of psilocybin, two weeks apart. Some psychotherapy was performed before and after the active psilocybin course.
The results were certainly impressive, with 71 per cent of the queue showing a reduction in depressive symptoms by more than 50 per cent in the four-week follow-up. A month later, the average depression score for the queue dropped from 23 to eight, with more than half of the group considered in remission.
“We’re seeing about four times more effects than clinical trials of traditional antidepressants on the market have shown,” said Alan Davis of Johns Hopkins University School of Medicine and co-author of the study. “Because most other depression treatments take weeks or months to work and may have adverse effects, these findings could be game-changing if they are established in future ‘gold standard’ placebo-controlled clinical trials.”
The study is not without limitations. It’s a small sample with no placebo control, so clearer data from larger trials is certainly important. In addition, only a short follow-up period limits the ability to understand the long-term benefits of the treatment.
However, Roland Griffiths, a pioneer in Psychedelic drug research, said it was impressive to see such results from a wide range of people with depression. Previous Psilocybin studies have focused on narrow mental health conditions, such as advanced cancer, but depression is a more common condition with a variety of manifestations.
“Because there are several types of severe depression that can lead to differences in people’s responses to treatment, I was surprised that most of our study participants found that psilocybin therapy was effective,” Griffiths said.
Philanthropist Tim Ferriss, who funded the preliminary study, called it “a vital proof of concept.” Ferriss, a well-known advocate of psychedelic medicine, says these promising results are only the beginning of a major shift in mental health.