Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients – Proof of Concept
Randomized double-blind placebo-controlled parallel Phase II study (n=55) of a single oral moderate dose psilocybin (0.215 mg/kg) plus short-term focused psychotherapy versus placebo in adults with mild-to-moderate MDD.
Details
Randomized, double-blind, placebo-controlled parallel trial testing a single oral dose of psilocybin (0.215 mg/kg) combined with short-term focused psychotherapy versus placebo in adults with mild-to-moderate major depressive disorder; mono-centric at Zurich.
Primary objectives include reduction in depressive symptoms and change in negative emotion processing bias assessed by fMRI; secondary measures include functional connectivity (e.g., amygdala–prefrontal) and plasma BDNF as a neuroplasticity biomarker.
Eligibility included adults 18–60, right-handed, drug-free, not at high suicide risk; exclusions included lifetime psychosis or bipolar disorder, recent substance dependence, abnormal ECG, BMI <17 or >35, and MRI contraindications.