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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Cybin IRL Limited • ClinicalTrials.gov ID: NCT06793397

Registry updated: 2026-10-16
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Description

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/

Interventions

  • CYB003 (Drug)
    CYB003 is a deuterated psilocin analog.
  • Psychological Support (Behavioral)
    Manualized psychological support performed by facilitator.

Eligibility criteria

Inclusion Criteria: Participants must meet all the following criteria to be included in the trial: * Age18 to 85 years. * Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of ≥4 weeks and ≤24 months\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60. * Moderate to severe depression at Screening and Baseline, independently confirmed. * Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator. * Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening. * Participant is able to refrain from nicotine use during the dosing session (up to 8 hours). * Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential. * Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing. * Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. * Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. Exclusion Criteria Participants with any of the following characteristics/conditions will be excluded from trial participation: * Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder. * Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD. * Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives). * Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening. * Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview. * Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months. * Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1. * Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening. * Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening. * Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \[including dyspepsia or gastroesophageal reflux disease\], hepatic, or renal disorder). * Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication. * Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate. * Participants have a presence or relevant history of organic brain disorders. * Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration. * Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing. * Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing. * Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing. * History of serotonin syndrome. * Unwilling to consent to audio and video recording of psychological support and dosing sessions.

Conditions

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

Locations

  • 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
  • Lipov Medical 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
  • K2 Medical Research Tampa — Tampa, 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
  • Atlas Psychiatry — New Orleans, Louisiana, United States
  • Johns Hopkins Medicine — Baltimore, Maryland, United States
  • Sunstone Medical, PC — Rockville, Maryland, United States
  • Adams Clinical Boston — Boston, Massachusetts, United States
  • Institute for Integrative Therapies — Eden Prairie, Minnesota, United States
  • The Remedy Mental Health — Golden Valley, Minnesota, United States
  • Redbird Research, LLC — Las Vegas, Nevada, United States
  • Bio Behavioral Health — Toms River, New Jersey, United States
  • Adams Clinical Harlem — New York, New York, United States
  • New York State Psychiatric Institute — New York, New York, United States
  • Davis Clinical (Adams Clinical Bronx) — The Bronx, New York, United States
  • Adams Clinical Watertown — Watertown, 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
  • Adams Clinical Dallas — DeSoto, 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
  • Edwardson Building - Campus for Ageing and Vitality — Newcastle upon Tyne, United Kingdom
  • Ascend Clinical Research — Reading, United Kingdom
  • Sheffield Health and Social Care NHS Foundation Trust — Sheffield, United Kingdom
  • Hollins Park Hospital, Winwick — Warrington, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record