Although Small Number Serious Adverse Events Were Reported
SafeMinds Shares has reported previously on psilocybin, a hallucinogenic/psychedelic substance that works by activating serotonin receptors in the prefrontal cortex, the area of the brain that affects mood, cognition, and perception. Early trials have shown that the psychedelic holds promise as an autism treatment since it supports the microbiome and normalizes serotonin levels. Now, results from the largest psilocybin trial have found the drug to be highly effective in managing the symptoms of treatment-resistant depression. Depression is common in autism spectrum disorder. In fact, individuals with autism are 4-times more likely to experience depression over their lifetime. In this important Phase 2b study, 233 patients were divided into three cohorts. One group received 25 milligrams of the drug, another group received 10 milligrams and the placebo group received 1 milligram. At the end of the study, the subjects given 25 milligrams of psilocybin experienced a significant decrease in depressive symptoms. Furthermore, these patients were still in remission three months after treatment. The 10-milligram group and 1-milligram group did not show improvements experienced by the higher dose group. However, the study did show cause for concern when unsettling side effect data surfaced. Overall, 12 patients in the trial reported treatment-emergent serious adverse events, five of whom were in the 25-milligram group, six in the 10-milligram group, and just one patient in the 1-milligram group. These serious adverse events included suicidal behavior and self-injury. Compass Pathways, the company developing psilocybin as a possible treatment, believe the numbers of adverse events in this trial are small enough to not be statistically significant. In the meantime, the U.S. Food and Drug Administration has granted the company a breakthrough therapy designation, which speeds up the drug approval process for psilocybin if the studies continue to show positive results.
