The treatment was well-tolerated, and no serious treatment-emergent adverse effects were identified.
In the study—a randomized, placebo-controlled, 6-week trial—the investigators aimed to evaluate the safety and efficacy of a single dose of psilocybin in patients with MDD. They examined the durability, timing, and scale of antidepressant effects in 104 adult patients aged 21 to 65 years after administration of either a 25-mg dose of psilocybin or placebo. Among the participants, the mean age was 41.1 years, and 52 were women.1
Participants were randomized to receive either psilocybin (51 participants) or a 100-mg dose of niacin (53 participants). All participants received psychological support in addition to psilocybin treatment or placebo.1
The investigators assessed primary and secondary outcomes, along with adverse events, at baseline (within 7 days before dosing) and again at 2, 8, 15, 29, and 43 days after dosing. They found that psilocybin treatment was associated with significantly reduced Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with niacin between baseline and day 43 (mean difference, −12.3 [95% CI, −17.5 to −7.2]; P < .001) and between baseline and day 8 (mean difference, −12.0 [95% CI, −16.6 to −7.4]; P < .001).1
They also found that psilocybin treatment was associated with significantly reduced Sheehan Disability Scale scores in comparison with niacin (mean difference, −2.31 [95% CI, 3.50-1.11]; P < .001) between baseline and day 43. They determined that the treatment was well-tolerated and identified no serious treatment-emergent adverse events.1
“Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events,” the investigators concluded. “These findings add to increasing evidence that psilocybin—when administered with psychological support—may hold promise as a novel intervention for MDD.”1
1. Raison CL, Sanacora G, Woolley J, et al. Single-dose psilocybin treatment for major depressive disorder: a randomized clinical trial. JAMA. August 31, 2023. Accessed August 31, 2023. https://jamanetwork.com/journals/jama/fullarticle/2808950