Pacific Neuroscience Institute (PNI) has initiated its psilocybin clinical trial that will investigate whether the compound can be an effective treatment for major depressive disorder (MDD).
Located at Providence Saint John’s Health Center, PNI will investigate the safety and efficacy of psilocybin for MDD, evaluating the potential antidepressant effects of a one-time dose.
PNI has begun participant enrolment for the trial. The Treatment & Research In Psychedelics (TRIP) program at Pacific Neuroscience is exploring how altered states of consciousness elicited by psychedelics can be harnessed to change behaviour and improve brain health.
TRIP programme director and addiction medicine specialist, Keith Heinzerling, MD, is the principal site investigator of the study.
Read more: Global coalition launches to push for psilocybin rescheduling
Heinzerling commented: “We are incredibly excited to be able to offer participation in this leading-edge clinical trial to people suffering with depression in Los Angeles and throughout Southern California.”
The PSIL201 Phase II, randomised, double-blinded, placebo-controlled, multi-site trial is sponsored by Usona Institute and began in 2019. Usona Institute will be providing the psilocybin for the trial as capsules.
A total of 100 participants with MDD who have no other medical conditions will be randomised to receive either a single dose of psilocybin or an active placebo.
The primary outcome measure will be change in a standardised depression rating scale (MADRS) 43 days after receiving psilocybin or placebo.
Daniel Kelly, MD, PNI director and founder, and site co-investigator of the study added: ”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.”
[activecampaign form=52]
