What This Study Is About:
This is the first psychedelic study designed to reflect real-world patients. Most clinical trials exclude people with multiple diagnoses, but that’s not how mental illness works in practice. We’re investigating psilocybin in individuals with co-occurring conditions — including PTSD, depression, anxiety, and substance use disorders — with a focus on veterans and first responders.

What This Study Is About:
One of the largest psychedelic clinical trials ever conducted. This Phase 3 study evaluates a single 25 mg dose of psilocybin versus placebo in adults with major depressive disorder. The trial includes one-year follow-up and the option for re-administration, providing some of the most comprehensive data on psilocybin’s sustained effects. ENACT serves as a participating site within this landmark multicenter investigation.

What This Study Is About:
A longitudinal extension study for participants who completed the EMBRACE trial. It assesses the long-term safety, tolerability, and durability of response, providing critical data on whether psilocybin’s therapeutic effects persist over time. This kind of long-term follow-up data is essential for both regulatory approval and clinical practice

What This Study Is About:
A pivotal Phase 3 registration study evaluating CYB003 (a deuterated psilocybin analog) in adults with major depressive disorder. This trial compares two active doses against placebo and is designed to support regulatory approval. ENACT’s participation in this industry-sponsored trial reflects the program’s expanding role in pivotal studies that could bring psychedelic therapies to market.

What This Study Is About:
Building on the findings from our landmark K23 trial, this study investigates whether repeated dosing of psilocybin produces more sustained benefits for OCD than a single dose. The trial uses a randomized, waitlist-controlled design with blinded independent raters, and assesses psychological mechanisms that may mediate psilocybin’s therapeutic effects.

Ongoing and planned neuroimaging work using functional MRI to examine the neural mechanisms underlying psilocybin’s therapeutic effects, with a focus on identifying predictive biomarkers of treatment response.

ENACT is developing precision medicine frameworks to understand why some individuals respond powerfully to psychedelic therapy while others do not. This work includes constitutional typology models, biomarker network analysis, and perturbation diagnostics — building toward the ability to match patients with optimal treatment approaches before a session begins.

This forthcoming study will investigate psilocybin-assisted therapy in a young adult population. Eligibility criteria, enrollment timelines, and study design details will be posted as the protocol is finalized and receives IRB approval.

About This Study:
This was the first randomized controlled trial of psilocybin for treatment-resistant OCD, and the first clinical psychedelic research funded by the National Institute of Mental Health since 1967. The study investigated a single 25 mg dose of psilocybin versus niacin placebo in adults with severe OCD who had failed multiple prior treatments. The protocol included integrated functional neuroimaging (fMRI) to examine neural mechanisms underlying therapeutic response. All intervention visits and assessments were completed per FDA IND requirements, and the database has been locked. Results have been submitted to a major medical journal.