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.
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.
Single oral moderate dose psilocybin (0.215 mg/kg) plus short-term focused psychotherapy.
Single dose 0.215 mg/kg psilocybin (oral)
Single oral placebo (100% mannitol) plus psychotherapy.
One oral dose of 100% mannitol (placebo)
In a randomized, placebo-controlled trial of 51 patients with major depression, a single dose of psilocybin (0.215 mg/kg) given alongside a four-week psychological support intervention produced significant increases in explicit emotional empathy—especially towards positive stimuli—relative to placebo that persisted for at least two weeks. The findings indicate that psychedelics can enhance social cognition in depression and may contribute to their therapeutic effects.