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Engaging Mood Brain Circuits with Psilocybin (EMBRACE): a study protocol for a randomized, placebo-controlled and delayed-start, neuroimaging trial in depression

Summary

This research study is investigating how psilocybin, a compound from certain mushrooms, affects the brain in people with depression. The study involves 50 participants who will receive either psilocybin or a placebo, with their brain activity monitored using advanced imaging scans. Researchers will examine how psilocybin changes blood flow and network activity in brain regions involved in mood regulation, and whether these changes are linked to improvements in depression symptoms.

Background

Major depressive disorder is a leading cause of global disability with approximately one-third of individuals not responding adequately to conventional antidepressants. Recent early phase trials suggest psilocybin may be a safe and efficacious intervention with rapid-acting antidepressant properties. Psilocybin is thought to exert therapeutic benefits by altering brain network connectivity and inducing neuroplastic changes that endure for weeks post-treatment.

Objective

The primary objective is to test whether psilocybin leads to significant acute and subacute changes in functional brain activity in networks associated with mood regulation and depression compared to placebo. Secondary objectives include examining whether participants treated with psilocybin-assisted psychotherapy have greater reduction in depression scores and exploring blood biomarkers mechanistically related to psilocybin and depression.

Results

This is a study protocol document describing planned methodology; results have not yet been generated as this is a registered trial (NCT06072898) that is being conducted.

Conclusion

This study will investigate the acute and additive subacute neuroplastic effects of psilocybin on brain networks affected by depression using advanced serial neuroimaging methods. Results will improve understanding of psilocybin’s antidepressant mechanisms versus placebo response and whether biological measures of brain function can provide early predictors of treatment response.
  • Published in:Trials,
  • Study Type:Clinical Trial,
  • Source: PMID: 38956594
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