Phase 3 Study of Psilocybin for Major Depressive Disorder (MDD)

Usona Institute has launched its Phase 3 study, "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)," also known as the uAspire trial. This research seeks to investigate the potential benefits and safety of psilocybin as a treatment option for individuals with MDD.

ClinicalTrials.gov Identifier: NCT06308653

Psilocybin Clinical Trial Phases | Usona Institute is between phase 2 and 3

PSIL201

This is the largest Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of a single dose of psilocybin to treat major depressive disorder. Psilocybin treatment was administered with psychosocial support, prioritizing optimal set and setting for study participants.

The results from PSIL201 can be viewed here.

PSIL102

This is a phase 1, two-part study evaluating two important clinical pharmacology questions:

1) Does psilocybin have the potential to delay cardiac repolarization (i.e., prolong the QT interval)?

2) Does consuming a meal prior to administration of psilocybin affect drug absorption?

Clinical conduct of PSIL102 is complete, and the study is closed to enrollment. We are currently analyzing the data from this study and plan to share the results in a future publication.

To learn more about the study please visit www.clinicaltrials.gov.

Breakthrough Therapy Designation

The FDA describes Breakthrough Therapy designation as “a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).“ In 2019, the FDA granted Breakthrough Therapy designation to Usona’s Investigational New Drug application for psilocybin as a potential treatment for major depressive disorder.

Expanded Access Policy

We do not offer expanded access at this time.

Psilocybin Overview

Usona has chemically synthesized psilocybin – a naturally occurring compound found in numerous species of Psilocybe mushrooms. For centuries, Indigenous peoples have used these mushrooms for spiritual and cultural purposes.

Psilocybin is known as a “classic psychedelic.”

Classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and LSD, can cause intense perceptual changes and an altered state of consciousness that can last for several hours.

Psilocybin Metabolism

When ingested, the phosphate group in the psilocybin molecule is metabolized to produce psilocin, a tryptamine alkaloid with psychoactive effects.

Drug Development

Psilocybin