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

PSIL201

This is the first Phase 2, randomized, double-blind, placebo-controlled study of single-dose psilocybin to treat major depressive disorder. The study is designed around a non-directive, supportive psychotherapeutic framework, prioritizing set and setting.

Usona’s Psilocybin for MDD clinical trial, PSIL201 is currently closed to enrollment. We are currently analyzing the data of this study and look forward to sharing results with you once available.

For more information, please see ct.gov.

PSIL201 LTFU

The PSIL201 Long Term Follow Up (LTFU) study is a 1 year observational follow up study of participants to assess symptoms of major depressive disorder at 6 months post intervention in participants treated with a single-dose of either psilocybin or niacin (active-controlled) in the PSIL201 study.

For more information, please see ct.gov.

PSIL102 TQT

The PSIL102 TQT study is a safety study evaluating a supratherapeutic dose of psilocybin on cardiac repolarization in healthy volunteers.

This study is currently closed to enrollment

PSIL102 - Food Effect (Part 2)

The Food Effect study is an open-label safety study evaluating the effect of food on the PK of a single 25mg dose of psilocybin in healthy volunteers

This study is currently open to enrollment.

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

To learn whether you qualify for this study being conducted in Overland Park, KS, please call 913-696-1601.

Breakthrough Therapy Designation

Per the FDA, “breakthrough therapy designation is 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).“

Expanded Access Policy

We do not offer expanded access at this time.

Psilocybin Overview

Usona has clinically 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 “classical psychedelic.”

Classical psychedelics have a dose-dependent capacity to create altered states of consciousness. Sensory perceptions, space-time orientation and emotional processing can be affected.

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

Clinical Research of Psilocybin

Clinical use began after Swiss chemist Dr. Albert Hoffman first isolated and synthesized psilocybin in the late 1950s. The next decade saw Sandoz, Ltd. market their drug Indocybin™ worldwide for experimental and psychotherapeutic use.

More than 1,000 papers exploring the effects of classic psychedelics were published in the 1970s. However, ongoing concerns around widespread non-medical use led to psilocybin being placed in the Controlled Substance Act Schedule I category in 1970. This effectively removed it from clinical use or scientific study for the next several decades.

Today, psilocybin remains a controlled substance globally. However, contemporary studies show promise for psilocybin administered in a supportive psychotherapeutic context.

Drug Development

Psilocybin

Current Psilocybin Clinical Trials