Engaging Mood Brain Circuits with Psilocybin (EMBRACE): a study protocol for a randomized, proof-of-principle, placebo-controlled and crossover, neuroimaging trial in depression
Research Square December 28, 2023 Joshua M. Poulin, Gregory E. Bigford, Krista L. Lanctôt et al. 1 citation
About one third of people with depression do not fully respond to standard treatments, and psilocybin may offer a rapid-acting alternative. This registered trial will randomize 36 adults with major depressive or persistent depressive disorder to receive either 25 mg psilocybin or an active placebo (100 mg niacin), then cross over three weeks later so that all participants receive psilocybin. Using serial neuroimaging, the study will test whether psilocybin acutely alters cerebral blood flow and functional brain activity in mood-related networks compared to placebo, and whether those changes persist subacutely. Clinical scales and serum biomarkers will also be collected to explore relationships with treatment response.