Psilocybin Mechanism of Action (MOA)

This randomised, quadruple-blind, placebo-controlled trial (n=60) will investigate the role of the 5-HT2A receptor in mediating the subjective and antidepressant effects of psilocybin in individuals with Major Depressive Disorder (MDD). Participants will receive a single dose of psilocybin (25mg) combined with either pimavanserin (34mg; atypical antipsychotic) or a placebo.

Conducted by the Icahn School of Medicine at Mount Sinai, this study aims to determine whether the antidepressant effects of psilocybin are independent of its psychedelic experience. Evaluations will be conducted before dosing and at multiple timepoints up to five weeks post-dosing.

The primary outcome measure is the Mystical Experience Questionnaire (MEQ-30) score, while secondary outcomes include changes in depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). The trial is expected to run from February 2025 to January 2028.

Topic Depression
Compound Psilocybin Placebo
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
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