A Randomized Neuroimaging Trial of Psilocybin in Depression
Randomised Phase II neuroimaging crossover trial (n=50) testing oral psilocybin 25 mg versus microcrystalline cellulose placebo in participants with depressive disorder; two treatment sessions with MRI assessments and supportive psychotherapy.
Details
This randomised, two-group delayed-start (AB/BB) crossover neuroimaging trial will compare brain activity after psilocybin 25 mg versus placebo (microcrystalline cellulose 25 mg) across two treatment sessions in patients with depressive disorder.
Participants undergo MRI after drug administration and prior to supportive psychotherapy at each session; primary outcomes assess changes in connectivity and regional blood flow in mood-related networks.
An interim analysis is planned after 20 participants to evaluate preliminary efficacy and safety; all participants receive supportive psychotherapy and clinical follow-up arrangements are required.