“Remarkable milestone for psychiatry”. Positive results in two large studies with psilocybin in patients with resistant depression.
A compound derived from psychedelic mushrooms, psilocybin, surpassed important results in two clinical trials large scale.
It is a breakthrough that paves the way for a formal application for approval from the United States Food and Drug Administration (FDA) for treatment for depression resistant to conventional therapiesthe biotech company announced this week.
Known for being the main psychoactive ingredient in so-called “magic mushrooms”, psilocybin has been the subject of intense scientific interest in recent years due to its therapeutic potential in mental health conditions that do not respond well to traditional antidepressants, recalls .
The proprietary synthetic version developed by Compass Pathways, called COMP360, has been shown to more effective than controls in reducing depressive symptoms in two large phase III trials.
In the first study, called COMP005, 258 participants with resistant depression received a single 25-milligram dose of COMP360 accompanied by psychological support, versus a placebo. The results showed that 25% of those who received the treatment experienced a reduction clinically significant of symptoms up to six weeks after the intervention.
In the second study, COMP006, the protocol involved 581 volunteers who received two doses of psilocybin (10 mg or 25 mg) or a 1 mg control group. In this essay, 39% of participants treated with the highest dose achieved relevant improvements in depressive symptoms in the same observation period.
According to the company, many of the participants responded quickly, com relief Symptoms are often observed the day after treatment.
Os side effects reported were, in general, light a moderate e disappeared within the next 24 hours.
Compass Pathways CEO Kabir Nath described the results as “a notable milestone” for psychiatryespecially in people with resistant depression, a traditionally difficult to treat population. Psilocybin works differently from classic antidepressants, which can take weeks to take effect, while the psychedelic substance seems to produce more immediate responses.
Despite the enthusiasm, experts warn that average benefits observed were modest, with improvements that may vary depending on the individual. Furthermore, it is still necessary to monitor long-term effects and ensure that the treatment is safe in broader clinical contexts.
Compass Pathways plans to formally submit applications for approval to the FDA in the fourth quarter of this year, a step that could make psilocybin one of the first regulated psychedelic treatments for depression and potentially usher in a new era in addressing mental health.
