Title {1} | Engaging Mood Brain Circuits with Psilocybin (EMBRACE): a study protocol for a randomized, single-center, placebo-controlled, delayed-start, neuroimaging trial in depression |
Trial registration {2a and 2b}. | EMBRACE Trial. ClinicalTrials.gov Identifier: NCT06072898. Registered on 6 October 2023. |
Protocol version {3} | Version 5 Dated June 2, 2024 |
Funding {4} | This trial has research seed funding from the Sunnybrook Foundation, with further support from the Canadian Institutes of Health Research (CIHR) Project Grant (165981). |
Author details {5a} |
1Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada 2Dr. Sandra Black Centre for Brain Resilience and Recovery, Toronto, Ontario, Canada 3Department of Medical Biophysics, University of Toronto, Toronto, Canada 4University of Miami, Florida, United States 5Harquail Centre for Neuromodulation, Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada 6Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada 7Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada 8Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada 9Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada 10Division of Neurosurgery, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada 11Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada 12Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada 13Mood Disorders Psychopharmacology Unit, Poul Hansen Family Centre for Depression, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada 14Research Design and Biostatistics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada |
Name and contact information for the trial sponsor {5b} | Sunnybrook Research Institute, Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. |
Role of sponsor {5c} | The sponsor did not have any role in the collection, management, analysis, and/or interpretation of the data; writing the report, or the decision to submit the report for publication. |