Single-Dose Psilocybin Treatment for Major Depressive Disorder
Findings In a randomized, placebo-controlled, 6-week trial in 104 adults, a 25-mg dose of psilocybin administered with psychological support was associated with a rapid and sustained antidepressant effect, measured as change in depressive symptom scores, compared with active placebo. No serious treatment-emergent adverse events occurred.
Meaning A 25-mg dose of psilocybin was well tolerated and may hold promise as a treatment for major depressive disorder when combined with psychological support.
Abstract
Importance Psilocybin shows promise as a treatment for major depressive disorder (MDD).
Objective To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD.
Design, Setting, and Participants In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were randomized in a 1:1 ratio to receive a single dose of psilocybin vs niacin placebo administered with psychological support.…


