Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression (PSILODAC)
Single-group interventional study (n=10) testing a single 25 mg oral dose of psilocybin with pre/post MRI in patients with treatment-resistant depression to assess effects on the positive valence system.
Details
This single-group study tests the hypothesis that psilocybin’s antidepressant effects are mediated by normalisation of the positive valence system, reducing anhedonia and increasing reward anticipation and motivation.
Psilocybin (single 25 mg oral dose) will be administered to patients with treatment-resistant major depressive episodes; outcomes include pre/post MRI of effort-evaluation circuits (amygdala, dACC, ventral pallidum, ventral striatum, VTA), depression and anhedonia scales, and behavioural measures with follow-up over four months.