100
Participants
Start Date
January 10, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2030
Psilocybin
A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (COMP360).
Accelerated intermittent theta burst (aiTBS) rTMS treatment
A form of non-invasive brain stimulation that delivers a series of quick magnetic pulses to the scalp and a portion of the brain. It will be targeted to a functional magnetic resonance imaging (fMRI) functional connectivity-guided personalized left dorsolateral prefrontal cortex target using neuronavigation and delivered over 10 sessions daily for 5 consecutive days at 90% of coil-to-target depth-corrected resting motor threshold.
Low-dose psilocybin
A psychedelic drug found in certain mushrooms. It will be in a low-dose form of the experimental dose as a 1mg capsule of psilocybin (COMP360).
Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment
The sham version is meant to look and feel like the active SAINT rTMS, but the main difference is that the brain is not being stimulated like the active condition.
RECRUITING
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600, Austin
University of Texas at Austin
OTHER