Approximately one third of people with depression do not respond to conventional treatments. In an effort to find an alternative therapy, researchers from the University of Toronto have launched a new study that will examine the potential of psilocybin for treating Major Depressive Disorder. The EMBRACE trial will investigate the substance’s effect on brain networks and its efficacy as a rapid-acting antidepressant.
The study will recruit 50 participants who are diagnosed with Major Depressive Disorder or Persistent Depressive Disorder. These participants will be placed in randomized groups, either psilocybin or placebo control. After three weeks, the control will transition to psilocybin treatment, which will allow researchers to compare the substance’s immediate and longer-term effects on the conditions.
Before and after taking the placebo, or psilocybin, participants will go through neuroimaging brain scans to help researchers observe changes in brain activity and blood flow, especially in areas associated with mood and depression. The study will also evaluate improvements in depressive symptoms using clinical psychiatric scales. Throughout the study, participants will receive supportive psychotherapy from trained therapists to help them process their experiences and integrate the effects of their psilocybin treatments into their daily lives.
Several clinical studies have supported the therapeutic potential of psilocybin as a treatment for depression. The psychoactive substance has even been granted breakthrough therapy designation by the FDA to expedite its development as a potentially more effective treatment compared to what’s already available.
The EMBRACE trial would add more evidence to the growing body of data supporting psilocybin’s effectiveness and help scientists better understand the mechanisms behind how psilocybin can alter brain function to alleviate depressive symptoms.The study is expected to begin recruitment in August 2024.
