{ "data": { "asOf": "2026-10-30T22:25:43.296Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06793397", "title": "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder", "scientificTitle": "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", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Major Depressive Disorder (MDD)", "Depression in Adults", "Depression - Major Depressive Disorder", "Depression Disorders", "Depression Disorder", "Depression" ], "interventions": [ { "name": "CYB003", "type": "DRUG", "description": "CYB003 is a deuterated psilocin analog." }, { "name": "Psychological Support", "type": "BEHAVIORAL", "description": "Manualized psychological support performed by facilitator." } ], "sponsor": { "name": "Cybin IRL Limited", "type": "INDUSTRY" }, "locations": [ { "city": "Birmingham", "country": "United States", "facility": "UAB Psychiatry and Behavioral Neurology" }, { "city": "Gilbert", "country": "United States", "facility": "Lighthouse Psychiatry" }, { "city": "Little Rock", "country": "United States", "facility": "Pillar Clinical Research - Little Rock" }, { "city": "Glendale", "country": "United States", "facility": "Behavioral Research Specialists, LLC" }, { "city": "Imperial", "country": "United States", "facility": "Sun Valley Research Center" }, { "city": "Los Angeles", "country": "United States", "facility": "CalNeuro Research Group" }, { "city": "Los Angeles", "country": "United States", "facility": "Lipov Medical Group" }, { "city": "Orange", "country": "United States", "facility": "ATP Clinical Research" }, { "city": "Orange", "country": "United States", "facility": "NRC Research Institute" }, { "city": "San Juan Capistrano", "country": "United States", "facility": "Inland Psychiatric Medical Group Inc (IPMG Research)" }, { "city": "Santa Monica", "country": "United States", "facility": "Psychedelic Science Institute" }, { "city": "Stanford", "country": "United States", "facility": "Stanford University" }, { "city": "New Haven", "country": "United States", "facility": "Yale School of Medicine - Yale Program for Psychedelic Science" }, { "city": "Jacksonville", "country": "United States", "facility": "CNS Healthcare" }, { "city": "Maitland", "country": "United States", "facility": "Accel Research Sites - Maitland" }, { "city": "Naples", "country": "United States", "facility": "Aqualane Clinical Research" }, { "city": "Tampa", "country": "United States", "facility": "K2 Medical Research Tampa" }, { "city": "Atlanta", "country": "United States", "facility": "Emory University Dept of Psychiatry and Behavioral Studies" }, { "city": "Marietta", "country": "United States", "facility": "Psych Atlanta" }, { "city": "Chicago", "country": "United States", "facility": "Rush University" }, { "city": "Marrero", "country": "United States", "facility": "Tandem Clinical Research" }, { "city": "New Orleans", "country": "United States", "facility": "Atlas Psychiatry" }, { "city": "Baltimore", "country": "United States", "facility": "Johns Hopkins Medicine" }, { "city": "Rockville", "country": "United States", "facility": "Sunstone Medical, PC" }, { "city": "Boston", "country": "United States", "facility": "Adams Clinical Boston" }, { "city": "Eden Prairie", "country": "United States", "facility": "Institute for Integrative Therapies" }, { "city": "Golden Valley", "country": "United States", "facility": "The Remedy Mental Health" }, { "city": "Las Vegas", "country": "United States", "facility": "Redbird Research, LLC" }, { "city": "Toms River", "country": "United States", "facility": "Bio Behavioral Health" }, { "city": "New York", "country": "United States", "facility": "Adams Clinical Harlem" }, { "city": "New York", "country": "United States", "facility": "New York State Psychiatric Institute" }, { "city": "The Bronx", "country": "United States", "facility": "Davis Clinical (Adams Clinical Bronx)" }, { "city": "Watertown", "country": "United States", "facility": "Adams Clinical Watertown" }, { "city": "Oklahoma City", "country": "United States", "facility": "SP Research PLLC" }, { "city": "Philadelphia", "country": "United States", "facility": "Adams Clinical Philadelphia" }, { "city": "Philadelphia", "country": "United States", "facility": "Flourish Research Philadelphia" }, { "city": "Austin", "country": "United States", "facility": "Austin Clinical Trial Partners" }, { "city": "DeSoto", "country": "United States", "facility": "Adams Clinical Dallas" }, { "city": "Fort Worth", "country": "United States", "facility": "North Texas Clinical Trials" }, { "city": "Houston", "country": "United States", "facility": "Brain Health Consultants and TMS Center" }, { "city": "San Antonio", "country": "United States", "facility": "Flourish Research San Antonio" }, { "city": "Everett", "country": "United States", "facility": "Core Clinical Research" }, { "city": "Seattle", "country": "United States", "facility": "Seattle Neuropsychiatric Treatment Center" }, { "city": "Camperdown", "country": "Australia", "facility": "Royal Prince Alfred Hospital" }, { "city": "Maroochydore", "country": "Australia", "facility": "Thompson Brain & Mind Healthcare (TBMH)" }, { "city": "Melbourne", "country": "Australia", "facility": "Ramsay Clinic" }, { "city": "Melbourne", "country": "Australia", "facility": "Neurocentrix Research" }, { "city": "Notting Hill", "country": "Australia", "facility": "Monash University - Notting Hill" }, { "city": "Prague", "country": "Czechia", "facility": "Institute of neuropsychiatric Care (INEP)" }, { "city": "Prague", "country": "Czechia", "facility": "Psyon s.r.o." }, { "city": "Předměstí", "country": "Czechia", "facility": "A-SHINE s.r.o." }, { "city": "Homburg", "country": "Germany", "facility": "Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes" }, { "city": "Berlin", "country": "Germany", "facility": "Charité Universitaetsmedizin Berlin" }, { "city": "Frankfurt am Main", "country": "Germany", "facility": "University Hospital Frankfurt" }, { "city": "Mannheim", "country": "Germany", "facility": "Central Institute of Mental Health" }, { "city": "Athens", "country": "Greece", "facility": "Eginitio Hospital" }, { "city": "Athens", "country": "Greece", "facility": "Attikon University Hospital" }, { "city": "Thessaloniki", "country": "Greece", "facility": "Papageorgiou General Hospital" }, { "city": "Dublin", "country": "Ireland", "facility": "Sheaf House - Tallaght Adult Mental Health Service" }, { "city": "Galway", "country": "Ireland", "facility": "La Nua Day Hospital Mental Health Centre" }, { "city": "Bialystok", "country": "Poland", "facility": "Uniwersytecki Szpital Kliniczny W Białymstoku" }, { "city": "Bydgoszcz", "country": "Poland", "facility": "Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy" }, { "city": "Gdansk", "country": "Poland", "facility": "UCK" }, { "city": "Gdansk", "country": "Poland", "facility": "Centrum Badan Klinicznych PI-House Sp. z o.o" }, { "city": "Warsaw", "country": "Poland", "facility": "MTZ Clinical Research Powered by Pratia" }, { "city": "Warsaw", "country": "Poland", "facility": "Department of Pharmacology and Physiology of CNS" }, { "city": "Cambridge", "country": "United Kingdom", "facility": "Cambridge University Hospital NHS" }, { "city": "Doncaster", "country": "United Kingdom", "facility": "Clerkenwell Health - Doncaster" }, { "city": "Edinburgh", "country": "United Kingdom", "facility": "NHS Research Scotland" }, { "city": "Glasgow", "country": "United Kingdom", "facility": "Queen Elizabeth University Hospital" }, { "city": "London", "country": "United Kingdom", "facility": "St Pancras Clinical Research" }, { "city": "London", "country": "United Kingdom", "facility": "King's College London" }, { "city": "London", "country": "United Kingdom", "facility": "Clerkenwell Health - Welbeck Street" }, { "city": "London", "country": "United Kingdom", "facility": "Re:Cognition Health" }, { "city": "London", "country": "United Kingdom", "facility": "Clerkenwell Health - Baker Street" }, { "city": "Newcastle upon Tyne", "country": "United Kingdom", "facility": "Edwardson Building - Campus for Ageing and Vitality" }, { "city": "Reading", "country": "United Kingdom", "facility": "Ascend Clinical Research" }, { "city": "Sheffield", "country": "United Kingdom", "facility": "Sheffield Health and Social Care NHS Foundation Trust" }, { "city": "Warrington", "country": "United Kingdom", "facility": "Hollins Park Hospital, Winwick" } ], "outcomes": { "other": [], "primary": [ "Montgomery-Asberg Depression Scale (MADRS)" ], "secondary": [ "The Beck Depression Inventory - Second Edition (BDI-II)", "The Clinical Global Impression Scale (CGI-S)", "The Generalized Anxiety Disorder 7-Item Scale (GAD-7)", "The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* 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.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* 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.\n* Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* 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.\n* 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.\n* 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.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics/conditions will be excluded from trial participation:\n\n* 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.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* 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.\n* 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.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* 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.\n* 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.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* 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).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* 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.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.", "maximumAge": "85 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 330 }, "startDate": "2025-12-10", "completionDate": "2027-08-09", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2025-01-27T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06793397" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06793397", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06793397", "sourceUrl": "https://clinicaltrials.gov/study/NCT06793397", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:33:21.755Z", "payloadSha256": "2d4fec0d27674b751fdbb0fe2af85cf2fec8a47cc3346486e2b93564ee6d757c", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06793397", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06793397", "verifyAt": "https://clinicaltrials.gov/study/NCT06793397", "retrievedAt": "2026-10-28T04:33:21.755Z", "payloadSha256": "2d4fec0d27674b751fdbb0fe2af85cf2fec8a47cc3346486e2b93564ee6d757c", "text": "ClinicalTrials.gov, record NCT06793397 (https://clinicaltrials.gov/study/NCT06793397), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06793397, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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