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UMass Chan Participates in Phase 3 Psilocybin Trials

By Tom Marino | January 2, 2024
Last Updated: January 2, 2024

WORCESTER – The Center for Psychopharmacologic Research and Treatment at UMass Chan Medical School has been selected to participate in a Phase III multicenter trial. The trial aims to evaluate the effectiveness of psilocybin, a compound found in “magic mushrooms,” in treating treatment-resistant depression.

Anthony Rothschild, MD, the Irving S. and Betty Brudnick Chair in Psychiatry and professor of psychiatry at UMass Chan, is leading the study Dr. Rothschild has a keen interest in exploring new treatments for depression, particularly for those patients who haven’t responded to conventional antidepressant medications.

“Psilocybin could offer a new treatment avenue for individuals who haven’t benefited from existing market options,” Dr. Rothschild noted.

This Phase III trial, sponsored by Compass Pathways, will use their proprietary formulation of synthetic psilocybin, COMP360. The therapy involves administering this compound in a clinical setting, supported by psychological counseling. UMass Chan is set to be the sole dosing site in New England for the study, which is scheduled to begin in January and will run for approximately 62 weeks. The plan includes enrolling at least 20 participants at UMass Chan.

“As a researcher on this study, I will learn how to provide psilocybin and if the drug were to get approved by the FDA, I would know how to set it up as a clinical option for people in the Worcester area who are suffering from treatment-resistant depression,” Rothschild said.

The trial consists of three stages: randomized treatment (psilocybin vs. placebo), re-randomization, and open-label treatment with psilocybin. Patients will undergo preparatory sessions with a therapist before the dosing sessions.

The dosing process spans three days, starting with pre-dosing therapy, followed by a six-to-eight-hour session with the therapist, and concluding with a reintegration session. All sessions will occur in a controlled environment.

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