The largest-ever study of the psychedelic drug psilocybin revealed that the drug is effective in treating serious depression.
The largest-ever study of the psychedelic drug psilocybin revealed Tuesday that the drug is effective in treating serious depression,The Compass Pathways study, which is the "largest randomized, controlled, double-blind trial of psilocybin," found that patients who were given the highest dose of the drug had a significant decrease in depressive symptoms as compared to the placebo group, per Stat.Subscribe for freeAbout 29.
The patients that received 25-milligram — the highest dose of the drug in the study — also experienced a "highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks," per Compass Pathways. Patients who received the lower 10-milligram dose did not experience a statistically significant difference after three weeks.The results of the study, which included 233 patients across Europe and North America, come after the Food and Drug Administration granted Compass Pathways a breakthrough therapy designation, paving the way for a potentially accelerated drug approval process, per Stat.The study also included data on patients who experienced adverse side effects from the drug.
Twelve patients reported treatment-emergent serious adverse events, including five who were in the 25-milligram group and six in the 10-milligram group. "The suicidal behaviors were reported at least one month after the administration of treatment and they occurred in patients who were essentially non-responding," Guy Goodwin, Compass’ chief medical officer, said Tuesday, per Stat.The results have not been published in a medical journal or peer-reviewed, according to Stat.Compass is in the early stages of beginning a Phase 3 trial next year, per Stat.
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