Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

Depression diminishes quality of life for civilians and Veterans with spinal cord injury (SCI), and depression rates are up to 2X higher in people with SCI than in people without SCI. Poor responsiveness to conventional antidepressants, along with comorbid conditions such as chronic pain, may worsen depression in people with SCI.

Psilocybin, the active compound in "magic mushrooms" activates pathways that may reduce the severity of depressive symptoms and the FDA designated psilocybin a Breakthrough Therapy for major depressive disorder in 2024.

The purpose of this study is to determine whether psilocybin is safe and well tolerated in people with SCI and whether psilocybin-assisted therapy reduces symptoms of depression. We will also evaluate the effects of psilocybin on pain, pain-related thoughts and behaviors, movement, sensation, autonomic functions such as blood pressure and heart rate regulation, and wellbeing and quality of life. These outcomes will be assessed through questionnaires, interviews, and standard evaluations, while monitoring any medical or psychological side effects throughout the study.

Thirty Veterans with chronic SCI will be enrolled: 15 people with paraplegia (T1 and below) and 15 with tetraplegia (C1-C8). Each participant will be randomly assigned to receive one dose of psilocybin: a low (5 mg), medium (10 mg), or high (25 mg). The study includes in-person and remote screening for both medical and mental health and once enrolled, 16 visits, consisting of a baseline evaluation, three preparatory and three integration therapy sessions, one psilocybin dosing session, and eight follow-up visits; three in-person visits at 1, 6, and 12 months after dosing and five remote visits.

This work is funded by the Department of Defense through grant # SC240097.

Details of this project can be found under the project identifier NCT07251491 at the following website: https://clinicaltrials.gov/study/NCT07251491


Principal Investigator

FEATURED PROJECTS

Contact the STOP Depression in Veterans With Spinal Cord Injury Study Team

Dr. Wenjie Ji, Ph.D.
Wenjie.Ji@va.gov
Wenjie.Ji@mountsinai.org
(718) 584-9000 Ext. 3132

130 West Kingsbridge Road
Bronx, NY 10468

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