RecruitingPhase 3NCT06793397

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

An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder

Sponsor

Cybin IRL Limited

Enrollment

330 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Depression - Major Depressive Disorder Depression in Adults Major Depressive Disorder (MDD)Depression Disorders Depression Disorder

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests CYB003, a modified form of psilocin (the active compound in psilocybin mushrooms), as a treatment for major depression in people who are already taking antidepressants but have not gotten full relief. The study investigates whether this psychedelic-assisted approach can help. **You may be eligible if...** - You are 18–85 years old with a diagnosis of moderate to severe major depressive disorder - You have been on a stable antidepressant dose for at least 4 weeks - Your BMI is 40 or below - You can refrain from smoking during the dosing session **You may NOT be eligible if...** - You have poorly controlled high blood pressure or serious heart conditions - You have a personal or family history of psychosis or certain psychiatric disorders - You are pregnant or trying to become pregnant - You have a history of substance abuse 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 facilitator.

Locations(67)

UAB Psychiatry and Behavioral Neurology

Birmingham, Alabama, United States

Lighthouse Psychiatry

Gilbert, Arizona, United States

Pillar Clinical Research - Little Rock

Little Rock, Arkansas, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Sun Valley Research Center

Imperial, California, United States

CalNeuro Research Group

Los Angeles, California, United States

ATP Clinical Research

Orange, California, United States

NRC Research Institute

Orange, California, United States

Inland Psychiatric Medical Group Inc (IPMG Research)

San Juan Capistrano, California, United States

Psychedelic Science Institute

Santa Monica, California, United States

Stanford University

Stanford, California, United States

Yale School of Medicine - Yale Program for Psychedelic Science

New Haven, Connecticut, United States

CNS Healthcare

Jacksonville, Florida, United States

Accel Research Sites - Maitland

Maitland, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Emory University Dept of Psychiatry and Behavioral Studies

Atlanta, Georgia, United States

Psych Atlanta

Marietta, Georgia, United States

Rush University

Chicago, Illinois, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Institute for Integrative Therapies

Eden Prairie, Minnesota, United States

Bio Behavioral Health

Toms River, New Jersey, United States

New York State Psychiatric Institute

New York, New York, United States

SP Research PLLC

Oklahoma City, Oklahoma, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Flourish Research Philadelphia

Philadelphia, Pennsylvania, United States

Austin Clinical Trial Partners

Austin, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

Brain Health Consultants and TMS Center

Houston, Texas, United States

Flourish Research San Antonio

San Antonio, Texas, United States

Core Clinical Research

Everett, Washington, United States

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Thompson Brain & Mind Healthcare (TBMH)

Maroochydore, Queensland, Australia

Ramsay Clinic

Melbourne, Victoria, Australia

Neurocentrix Research

Melbourne, Victoria, Australia

Monash University - Notting Hill

Notting Hill, Victoria, Australia

Institute of neuropsychiatric Care (INEP)

Prague, Czechia

Psyon s.r.o.

Prague, Czechia

A-SHINE s.r.o.

Předměstí, Czechia

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes

Homburg, Saarland, Germany

Charité Universitaetsmedizin Berlin

Berlin, Germany

University Hospital Frankfurt

Frankfurt am Main, Germany

Central Institute of Mental Health

Mannheim, Germany

Eginitio Hospital

Athens, Greece

Attikon University Hospital

Athens, Greece

Papageorgiou General Hospital

Thessaloniki, Greece

Sheaf House - Tallaght Adult Mental Health Service

Dublin, Ireland

La Nua Day Hospital Mental Health Centre

Galway, Ireland

Uniwersytecki Szpital Kliniczny W Białymstoku

Bialystok, Poland

Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy

Bydgoszcz, Poland

UCK

Gdansk, Poland

Centrum Badan Klinicznych PI-House Sp. z o.o

Gdansk, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Department of Pharmacology and Physiology of CNS

Warsaw, Poland

Cambridge University Hospital NHS

Cambridge, United Kingdom

Clerkenwell Health - Doncaster

Doncaster, United Kingdom

NHS Research Scotland

Edinburgh, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

St Pancras Clinical Research

London, United Kingdom

King's College London

London, United Kingdom

Clerkenwell Health - Welbeck Street

London, United Kingdom

Re:Cognition Health

London, United Kingdom

Clerkenwell Health - Baker Street

London, United Kingdom

Wolfson Unit - Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Ascend Clinical Research

Reading, United Kingdom

Sheffield Health and Social Care NHS Foundation Trust

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06793397

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