Significant benefit seen as early as eight days compared with placebo
By Lori Solomon HealthDay Reporter
TUESDAY, Sept. 5, 2023 (HealthDay News) — Psilocybin treatment is associated with a clinically significant sustained reduction in depressive symptoms and functional disability in individuals with major depressive disorder (MDD), according to a phase 2 study published online Aug. 31 in the Journal of the American Medical Association.
Charles L. Raison, M.D., from Usona Institute in Fitchburg, Wisconsin, and colleagues evaluated the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. The analysis included 104 adults (aged 21 to 65 years) with MDD who were randomly assigned (1:1) to receive a single dose of psilocybin or niacin placebo.
The researchers found that psilocybin treatment was associated with significantly reduced Montgomery-Asberg Depression Rating Scale scores versus niacin from baseline to day 43 (mean difference, −12.3; P < 0.001) and from baseline to day 8 (mean difference, −12.0; P < 0.001). There was also a significant reduction in Sheehan Disability Scale scores for psilocybin treatment compared with niacin (mean difference, −2.31; P < 0.001) from baseline to day 43. Compared with niacin treatment, more participants receiving psilocybin had sustained response (but not remission). Psilocybin treatment was associated with a higher rate of overall adverse events (AEs) and a higher rate of severe AEs, but there were no serious treatment-emergent AEs.
“These findings add to increasing evidence that psilocybin — when administered with psychological support — may hold promise as a novel intervention for MDD,†the authors write.
Several authors disclosed ties to the pharmaceutical industry.
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