RecruitingPhase 3NCT06793397

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

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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/ (The sponsor's summary, shortened.)

Eligibility and contacts on ClinicalTrials.gov

The registry record

Status: Recruiting
Phase: Phase 3
Conditions: Major Depressive Disorder (MDD); Depression in Adults; Depression - Major Depressive Disorder; Depression Disorders; Depression Disorder; Depression
Intervention: CYB003; Psychological Support
Sponsor: Cybin IRL Limited
Ages: 18 Years to 85 Years
Sex: All
Healthy volunteers: No
Enrolment: 330 people (planned)
Start: 10 December 2025
Primary completion: 7 June 2027
Registry last updated: 27 October 2026

Sites (79)

UAB Psychiatry and Behavioral Neurology, Birmingham, Alabama, United States (recruiting)
Lighthouse Psychiatry, Gilbert, Arizona, United States (recruiting)
Pillar Clinical Research - Little Rock, Little Rock, Arkansas, United States (withdrawn)
Behavioral Research Specialists, LLC, Glendale, California, United States (recruiting)
Sun Valley Research Center, Imperial, California, United States (withdrawn)
CalNeuro Research Group, Los Angeles, California, United States (recruiting)
Lipov Medical Group, Los Angeles, California, United States (recruiting)
ATP Clinical Research, Orange, California, United States (recruiting)
NRC Research Institute, Orange, California, United States (recruiting)
Inland Psychiatric Medical Group Inc (IPMG Research), San Juan Capistrano, California, United States (not yet recruiting)
Psychedelic Science Institute, Santa Monica, California, United States (recruiting)
Stanford University, Stanford, California, United States (withdrawn)
Yale School of Medicine - Yale Program for Psychedelic Science, New Haven, Connecticut, United States (recruiting)
CNS Healthcare, Jacksonville, Florida, United States (recruiting)
Accel Research Sites - Maitland, Maitland, Florida, United States (recruiting)
Aqualane Clinical Research, Naples, Florida, United States (recruiting)
K2 Medical Research Tampa, Tampa, Florida, United States (recruiting)
Emory University Dept of Psychiatry and Behavioral Studies, Atlanta, Georgia, United States (withdrawn)
Psych Atlanta, Marietta, Georgia, United States (recruiting)
Rush University, Chicago, Illinois, United States (recruiting)
Tandem Clinical Research, Marrero, Louisiana, United States (withdrawn)
Atlas Psychiatry, New Orleans, Louisiana, United States (recruiting)
Johns Hopkins Medicine, Baltimore, Maryland, United States (withdrawn)
Sunstone Medical, PC, Rockville, Maryland, United States (not yet recruiting)
Adams Clinical Boston, Boston, Massachusetts, United States (recruiting)
Institute for Integrative Therapies, Eden Prairie, Minnesota, United States (recruiting)
The Remedy Mental Health, Golden Valley, Minnesota, United States (not yet recruiting)
Redbird Research, LLC, Las Vegas, Nevada, United States (recruiting)
Bio Behavioral Health, Toms River, New Jersey, United States (recruiting)
Adams Clinical Harlem, New York, New York, United States (recruiting)
New York State Psychiatric Institute, New York, New York, United States (not yet recruiting)
Davis Clinical (Adams Clinical Bronx), The Bronx, New York, United States (recruiting)
Adams Clinical Watertown, Watertown, New York, United States (recruiting)
SP Research PLLC, Oklahoma City, Oklahoma, United States (withdrawn)
Adams Clinical Philadelphia, Philadelphia, Pennsylvania, United States (recruiting)
Flourish Research Philadelphia, Philadelphia, Pennsylvania, United States (recruiting)
Austin Clinical Trial Partners, Austin, Texas, United States (withdrawn)
Adams Clinical Dallas, DeSoto, Texas, United States (recruiting)
North Texas Clinical Trials, Fort Worth, Texas, United States (withdrawn)
Brain Health Consultants and TMS Center, Houston, Texas, United States (recruiting)
Flourish Research San Antonio, San Antonio, Texas, United States (recruiting)
Core Clinical Research, Everett, Washington, United States (not yet recruiting)
Seattle Neuropsychiatric Treatment Center, Seattle, Washington, United States (recruiting)
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia (recruiting)
Thompson Brain & Mind Healthcare (TBMH), Maroochydore, Queensland, Australia (recruiting)
Ramsay Clinic, Melbourne, Victoria, Australia (recruiting)
Neurocentrix Research, Melbourne, Victoria, Australia (recruiting)
Monash University - Notting Hill, Notting Hill, Victoria, Australia (recruiting)
Institute of neuropsychiatric Care (INEP), Prague, Czechia (not yet recruiting)
Psyon s.r.o., Prague, Czechia (not yet recruiting)
A-SHINE s.r.o., Předměstí, Czechia (not yet recruiting)
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg, Saarland, Germany (not yet recruiting)
Charité Universitaetsmedizin Berlin, Berlin, Germany (not yet recruiting)
University Hospital Frankfurt, Frankfurt am Main, Germany (not yet recruiting)
Central Institute of Mental Health, Mannheim, Germany (not yet recruiting)
Eginitio Hospital, Athens, Greece (recruiting)
Attikon University Hospital, Athens, Greece (recruiting)
Papageorgiou General Hospital, Thessaloniki, Greece (recruiting)
Sheaf House - Tallaght Adult Mental Health Service, Dublin, Ireland (recruiting)
La Nua Day Hospital Mental Health Centre, Galway, Ireland (recruiting)
Uniwersytecki Szpital Kliniczny W Białymstoku, Bialystok, Poland (withdrawn)
Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy, Bydgoszcz, Poland (recruiting)
UCK, Gdansk, Poland (not yet recruiting)
Centrum Badan Klinicznych PI-House Sp. z o.o, Gdansk, Poland (recruiting)
MTZ Clinical Research Powered by Pratia, Warsaw, Poland (recruiting)
Department of Pharmacology and Physiology of CNS, Warsaw, Poland (not yet recruiting)
Cambridge University Hospital NHS, Cambridge, United Kingdom (recruiting)
Clerkenwell Health - Doncaster, Doncaster, United Kingdom (recruiting)
NHS Research Scotland, Edinburgh, United Kingdom (not yet recruiting)
Queen Elizabeth University Hospital, Glasgow, United Kingdom (not yet recruiting)
St Pancras Clinical Research, London, United Kingdom (recruiting)
King's College London, London, United Kingdom (recruiting)
Clerkenwell Health - Welbeck Street, London, United Kingdom (withdrawn)
Re:Cognition Health, London, United Kingdom (recruiting)
Clerkenwell Health - Baker Street, London, United Kingdom (recruiting)
Edwardson Building - Campus for Ageing and Vitality, Newcastle upon Tyne, United Kingdom (recruiting)
Ascend Clinical Research, Reading, United Kingdom (recruiting)
Sheffield Health and Social Care NHS Foundation Trust, Sheffield, United Kingdom (recruiting)
Hollins Park Hospital, Winwick, Warrington, United Kingdom (not yet recruiting)

How joining a trial works

Free to take part: Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
Screened first: Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
Eligibility is strict: Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
You may get a placebo: Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
Contact the study team through the registry: Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
Not medical advice: This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications

Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.

Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials