Psilocybin Clinical Trial for Depression Launches at Pacific Neuroscience Institute

Now recruiting participants for psilocybin to be used for treatment of major depressive disorder.

SANTA MONICA, Calif., Jan. 12, 2022 /PRNewswire/ — Pacific Neuroscience Institute (PNI) located at Providence Saint John’s Health Center, has activated a new psilocybin clinical trial and has begun participant enrollment.

The PSIL201 study is investigating the safety and efficacy of psilocybin for major depressive disorder (MDD). It will evaluate the potential antidepressant effects of a one-time dose of psilocybin.

PSIL201

Sponsored by Usona Institute, PSIL201 is a Phase 2, randomized, double-blinded, placebo-controlled, multi-site study which began in 2019. A total of 100 otherwise medically healthy participants with MDD will be randomized to receive either a single dose of psilocybin or an active placebo (niacin). The primary outcome measure will be change in a standardized depression rating scale (MADRS) 43 days after receiving psilocybin or placebo. Psilocybin, the active ingredient in magic mushrooms, is provided as capsules by Usona Institute and considered non-addictive.

About TRIP

The Treatment & Research In Psychedelics (TRIP) program at Pacific Neuroscience Institute is exploring how altered states of consciousness elicited by psychedelics can be harnessed to change behavior and improve brain health. TRIP program director and addiction medicine specialist, Keith Heinzerling, MD, is the principal site investigator of the PSIL201 study at PNI.

“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,” said Dr. Heinzerling.

About Depression

There has been renewed research interest in psilocybin therapies over the past two decades to treat mental health conditions including addiction, anxiety, PTSD, and depression. Major depressive disorder is a global health crisis and has become the leading cause of disability, affecting over 300 million people worldwide. One in six individuals in the United States will experience an episode of major depression in their lifetime. Additionally, depression is associated with more disability than most other chronic illnesses and is a risk factor for mortality.

“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, PNI Director and Founder, and site co-investigator of the study.

More information can be found on the TRIP website and at ClinicalTrials.gov.

Adapted from original article published on PR Newswire.