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

NCT06793397 · Cybin IRL Limited
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Official title
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
About this study
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 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. * Moderate to severe depression at Screening. * Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to Screening. * Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening. * Participants with well controlled hypertension. * Participant is able to refrain from smoking during the dosing session. * Participants must use a condom plus spermicide during the trial and for 12 weeks afterwards. Participants of childbearing potential must agree to use a highly effective method of and 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. * Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives). * Significant suicide risk within 12 months of Screening. * Current or previous diagnosis of treatment-resistant MDD. * 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. * 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 hydroxytryptophan or St John's Wort within prior to trial medication administration. * Strenuous exercise prior to each clinic visit. * 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.
Study design
Enrollment target: 330 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-10
Estimated completion: 2027-05-08
Last updated: 2026-04-13
Interventions
Drug: CYB003Behavioral: Psychological Support
Primary outcomes
  • Montgomery-Asberg Depression Scale (MADRS) (Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.)
Sponsor
Cybin IRL Limited · industry
With: Worldwide Clinical Trials
Contacts & investigators
ContactClinical Development · contact · clinicaltrialsinfo@cybin.com · 1-866-292-4601 x799
InvestigatorFelix Mazer · study_director, Cybin IRL Limited
All locations (67)
UAB Psychiatry and Behavioral NeurologyRecruiting
Birmingham, Alabama, United States
Lighthouse PsychiatryRecruiting
Gilbert, Arizona, United States
Pillar Clinical Research - Little RockNot Yet Recruiting
Little Rock, Arkansas, United States
Behavioral Research Specialists, LLCNot Yet Recruiting
Glendale, California, United States
Sun Valley Research CenterNot Yet Recruiting
Imperial, California, United States
CalNeuro Research GroupRecruiting
Los Angeles, California, United States
ATP Clinical ResearchNot Yet Recruiting
Orange, California, United States
NRC Research InstituteNot Yet Recruiting
Orange, California, United States
Inland Psychiatric Medical Group Inc (IPMG Research)Not Yet Recruiting
San Juan Capistrano, California, United States
Psychedelic Science InstituteRecruiting
Santa Monica, California, United States
Stanford UniversityNot Yet Recruiting
Stanford, California, United States
Yale School of Medicine - Yale Program for Psychedelic ScienceRecruiting
New Haven, Connecticut, United States
CNS HealthcareRecruiting
Jacksonville, Florida, United States
Accel Research Sites - MaitlandRecruiting
Maitland, Florida, United States
Aqualane Clinical ResearchRecruiting
Naples, Florida, United States
Emory University Dept of Psychiatry and Behavioral StudiesNot Yet Recruiting
Atlanta, Georgia, United States
Psych AtlantaRecruiting
Marietta, Georgia, United States
Rush UniversityRecruiting
Chicago, Illinois, United States
Tandem Clinical ResearchNot Yet Recruiting
Marrero, Louisiana, United States
Johns Hopkins MedicineNot Yet Recruiting
Baltimore, Maryland, United States
Institute for Integrative TherapiesRecruiting
Eden Prairie, Minnesota, United States
Bio Behavioral HealthRecruiting
Toms River, New Jersey, United States
New York State Psychiatric InstituteNot Yet Recruiting
New York, New York, United States
SP Research PLLCNot Yet Recruiting
Oklahoma City, Oklahoma, United States
Adams Clinical PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Flourish Research PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Austin Clinical Trial PartnersNot Yet Recruiting
Austin, Texas, United States
North Texas Clinical TrialsNot Yet Recruiting
Fort Worth, Texas, United States
Brain Health Consultants and TMS CenterRecruiting
Houston, Texas, United States
Flourish Research San AntonioRecruiting
San Antonio, Texas, United States
Core Clinical ResearchNot Yet Recruiting
Everett, Washington, United States
Seattle Neuropsychiatric Treatment CenterNot Yet Recruiting
Seattle, Washington, United States
Royal Prince Alfred HospitalNot Yet Recruiting
Camperdown, New South Wales, Australia
Thompson Brain & Mind Healthcare (TBMH)Recruiting
Maroochydore, Queensland, Australia
Ramsay ClinicRecruiting
Melbourne, Victoria, Australia
Neurocentrix ResearchNot Yet Recruiting
Melbourne, Victoria, Australia
Monash University - Notting HillRecruiting
Notting Hill, Victoria, Australia
Institute of neuropsychiatric Care (INEP)Not Yet Recruiting
Prague, Czechia
Psyon s.r.o.Not Yet Recruiting
Prague, Czechia
A-SHINE s.r.o.Not Yet Recruiting
Předměstí, Czechia
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des SaarlandesNot Yet Recruiting
Homburg, Saarland, Germany
Charité Universitaetsmedizin BerlinNot Yet Recruiting
Berlin, Germany
University Hospital FrankfurtNot Yet Recruiting
Frankfurt am Main, Germany
Central Institute of Mental HealthNot Yet Recruiting
Mannheim, Germany
Eginitio HospitalRecruiting
Athens, Greece
Attikon University HospitalRecruiting
Athens, Greece
Papageorgiou General HospitalRecruiting
Thessaloniki, Greece
Sheaf House - Tallaght Adult Mental Health ServiceRecruiting
Dublin, Ireland
La Nua Day Hospital Mental Health CentreRecruiting
Galway, Ireland
Uniwersytecki Szpital Kliniczny W BiałymstokuNot Yet Recruiting
Bialystok, Poland
Promente - Centrum Neurologii i Psychogeriatrii w BydgoszczyRecruiting
Bydgoszcz, Poland
UCKNot Yet Recruiting
Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.oNot Yet Recruiting
Gdansk, Poland
MTZ Clinical Research Powered by PratiaNot Yet Recruiting
Warsaw, Poland
Department of Pharmacology and Physiology of CNSNot Yet Recruiting
Warsaw, Poland
Cambridge University Hospital NHSNot Yet Recruiting
Cambridge, United Kingdom
Clerkenwell Health - DoncasterRecruiting
Doncaster, United Kingdom
NHS Research ScotlandNot Yet Recruiting
Edinburgh, United Kingdom
Queen Elizabeth University HospitalNot Yet Recruiting
Glasgow, United Kingdom
St Pancras Clinical ResearchNot Yet Recruiting
London, United Kingdom
King's College LondonNot Yet Recruiting
London, United Kingdom
Clerkenwell Health - Welbeck StreetRecruiting
London, United Kingdom
Re:Cognition HealthRecruiting
London, United Kingdom
Clerkenwell Health - Baker StreetRecruiting
London, United Kingdom
Wolfson Unit - Cumbria, Northumberland, Tyne and Wear NHS Foundation TrustNot Yet Recruiting
Newcastle upon Tyne, United Kingdom
Ascend Clinical ResearchRecruiting
Reading, United Kingdom
Sheffield Health and Social Care NHS Foundation TrustNot Yet Recruiting
Sheffield, United Kingdom
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder · TrialPath