New trial will assess psilocybin for depression treatment

Pacific Neuroscience Institute announced the start of a new clinical trial to assess the safety and efficacy of psilocybin to treat major depressive disorder and has begun participant enrollment, according to a company release.

The trial will be a continuation of the PSIL201 study, begun as a phase 2, randomized, double-blinded, placebo-controlled, multi-site study sponsored by Usona Institute, which began in 2019.

A total of 100 otherwise healthy participants diagnosed with MDD will be randomly assigned to receive either a single dose of psilocybin in capsule form or placebo.

Effectiveness of the dosage will be measured by changes based on a standardized depression rating scale, 43 days after receiving either psilocybin or placebo.

“Given the huge demand for more effective and durable depression therapies, we are thrilled to be joining Usona Institute for this ongoing trial and are hopeful the final results will justify a larger Phase 3 Efficacy trial,” said Daniel Kelly, MD, Pacific Neuroscience Institute director and founder, and site co-investigator of the study.