RecruitingPhase 3NCT06564818

"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

Sponsor

Cybin IRL Limited

Enrollment

220 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CYB003 — a modified, deuterated analog of psilocin (the active compound in psilocybin mushrooms) — in adults with treatment-resistant or inadequate-response major depression. The goal is to determine a safe dose and see whether it helps when added to an ongoing antidepressant. **You may be eligible if...** - You are age 18–85 with a diagnosis of moderate-to-severe major depressive disorder (MDD) - Your first episode of depression started before age 60 - You are on a stable antidepressant dose but have not had a good response (less than 50% improvement) - Your BMI is 40 or below - You are able to refrain from nicotine for up to 8 hours during dosing sessions - You are registered with a healthcare provider who can confirm your diagnosis and treatment history **You may NOT be eligible if...** - You have a history of psychosis, bipolar disorder, or certain other psychiatric conditions - You have active suicidal intent - You have serious liver, kidney, or heart problems - You are pregnant or breastfeeding - You use substances that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYB003

CYB003 is a Deuterated Psilocin Analog.

BEHAVIORALPsychological Support

Manualized psychological support performed by facilitators

DRUGPlacebo

Placebo

Locations(47)

Scottsdale Research Institute

Phoenix, Arizona, United States

Mountain Clinical Trials

Phoenix, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

CenExel CIT (Clinical Innovations, Inc)

Bellflower, California, United States

Kadima Neuropsychiatry Institute

La Jolla, California, United States

Bespoke Treatment/Lipov Medical Group

Los Angeles, California, United States

Catalina Research Institute

Montclair, California, United States

Excell Research, Inc

Oceanside, California, United States

Open Mind Therapeutics

San Francisco, California, United States

Inland Psychiatric Medical Group Inc

San Juan Capistrano, California, United States

Mountain View Clinical Research

Denver, Colorado, United States

Starlight Clinical Research

Evergreen, Colorado, United States

Research Centers of America

Hollywood, Florida, United States

K2 Medical Research-Maitland

Maitland, Florida, United States

Floridian Neuroscience Institute

Miami, Florida, United States

Segal Trials West Broward

North Miami, Florida, United States

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Charter Research

Orlando, Florida, United States

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

K2 Medical Research - Tampa

Tampa, Florida, United States

Atlanta Center for Medical Research, CenExel

Atlanta, Georgia, United States

CenExel iResearch Atlanta

Decatur, Georgia, United States

CenExel iResearch Savannah

Savannah, Georgia, United States

Great Lakes Clinical Trials, DBA Flourish Research

Chicago, Illinois, United States

Uptown Research Institute

Chicago, Illinois, United States

Psychiatric Medicine Associates, LLC

Skokie, Illinois, United States

Atlas Psychiatric

New Orleans, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

Sunstone Medical, PC

Rockville, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Adams Clinical

Boston, Massachusetts, United States

Elixia Health

Springfield, Massachusetts, United States

Redbird Research, LLC

Las Vegas, Nevada, United States

Oasis Clinical Trials

Las Vegas, Nevada, United States

Global Medical Institutes, Princeton Medical Institute

Princeton, New Jersey, United States

Adams Clinical Harlem

New York, New York, United States

Adams Clinical Bronx

The Bronx, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Neurobehavioral Clinical Research

North Canton, Ohio, United States

SP Research

Oklahoma City, Oklahoma, United States

Clinical Neuroscience Solutions, CNS Healthcare

Memphis, Tennessee, United States

InSite Clinical Research, LLC

DeSota, Texas, United States

Zillan Clinical Research

Houston, Texas, United States

AIM Trials

Plano, Texas, United States

Cedar Clinical Research

Murray, Utah, United States

Inner Space Research, LLC

Orem, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06564818

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"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(47)

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