A Randomized Neuroimaging Trial of Psilocybin in Depression
Status:
Not yet recruiting
Trial end date:
2027-11-01
Target enrollment:
Participant gender:
Summary
The goal of this neuroimaging clinical trial is to test whether psilocybin produces
significant immediate changes in functional brain activity in networks associated with mood
regulation and depression compared to placebo in patients with depression. The trial aims to
determine if psilocybin:
1. Changes connectivity within brain networks associated with mood and depression
2. Changes blood flow in brain regions associated with mood and depression
Participants will be attend two treatment sessions where they receive an oral medication and
supportive psychotherapy. At each session, participants will undergo an MRI scan after drug
administration but prior to psychotherapy. Participants will be randomly to assigned to one
of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and
psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively.
Differences between groups will be compared to understand what effects on brain activity are
specific to psilocybin.