"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
NCT ID: NCT06564818
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2024-12-17
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions
Arm A participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study.
CYB003
CYB003 is a Deuterated Psilocin Analog.
Psychological Support
Manualized psychological support performed by facilitators
Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions
Arm B participants will receive placebo in 2 of 2 Dosing Sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial.
Psychological Support
Manualized psychological support performed by facilitators
Placebo
Placebo
Interventions
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CYB003
CYB003 is a Deuterated Psilocin Analog.
Psychological Support
Manualized psychological support performed by facilitators
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 85 years inclusive, at Screening
* 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.
* Depression is of moderate to severe degree at Screening, independently confirmed by additional clinical assessments
* Participant has been on a stable dose of a single antidepressant medication at an adequate dose (label specified) for an adequate duration in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator and clinical interviews.
* 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)
* Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant.
* Participants capable of producing sperm must use a condom during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from first dosing until 12 weeks following final dosing.
* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) 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.
* Female participants who were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle-stimulating hormone level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.
* Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.
Exclusion Criteria
* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, attention deficit hyperactivity disorder, current or previous history of bipolar disorder, or current borderline personality disorder.
* 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 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 antidepressant, mirtazapine, trazodone, moclobemide, buspirone, ketamine or S-ketamine, or an antipsychotic or mood stabilizer for MDD.
* 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 4 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.
* Clinically relevant history of abnormal physical health interfering with the trial as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \[including dyspepsia or gastroesophageal reflux disease\], hepatic, or renal disorder).
* Participants with renal insufficiency.
* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication with no change in dosage for at least 12 weeks prior to Screening.
* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate or blood pressure
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the trial medication.
* Participant has a presence or relevant history of organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).
* Known sensitivity to psilocin and/or any excipients present in the formulation.
* Participant is taking or has taken OTC doses of 5 hydroxytryptophan or St John's Wort within 45 days prior to trial medication administration.
* Strenuous exercise within 48 hours prior to each clinic visit.
* The participant has participated in a clinical trial and has received a medication or a new chemical entity within 12 weeks prior to dosing of current trial medication.
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Cybin IRL Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_CHAIR
Cybin IRL Limited
Locations
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Scottsdale Research Institute
Phoenix, Arizona, United States
Mountain Clinical Trials
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Del Sol Research Management
Tucson, Arizona, United States
CenExel CIT (Clinical Innovations, Inc)
Bellflower, California, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Bespoke Treatment/Lipov Medical Group
Los Angeles, California, United States
Catalina Research Institute
Montclair, California, United States
Excell Research, Inc
Oceanside, California, United States
Open Mind Collective/UCSF Medical Center Mount Zion
San Francisco, California, United States
Inland Psychiatric Medical Group Inc
San Juan Capistrano, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Starlight Clinical Research
Evergreen, Colorado, United States
Research Centers of America
Hollywood, Florida, United States
K2 Medical Research-Maitland
Maitland, Florida, United States
Floridian Neuroscience Institute
Miami, Florida, United States
Innovative Clinical Research, INC
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Charter Research
Orlando, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
K2 Medical Research-Tampa
Tampa, Florida, United States
Atlanta Center for Medical Research, CenExel
Atlanta, Georgia, United States
CenExel iResearch Atlanta
Decatur, Georgia, United States
CenExel iResearch Savannah
Savannah, Georgia, United States
Great Lakes Clinical Trials, DBA Flourish Research
Chicago, Illinois, United States
Uptown Research Institute
Chicago, Illinois, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States
DelRicht Research
New Orleans, Louisiana, United States
Sunstone Medical, PC
Rockville, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Adams Clinical
Boston, Massachusetts, United States
Elixia Health
Springfield, Massachusetts, United States
Redbird Research, LLC
Las Vegas, Nevada, United States
Oasis Clinical Trials
Las Vegas, Nevada, United States
Global Medical Institues, Princeton Medical Institute
Princeton, New Jersey, United States
Adams Clinical Harlem
New York, New York, United States
Adams Clinical Bronx
The Bronx, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Neurobehavioral Clinical Research
North Canton, Ohio, United States
Clinical Neuroscience Solutions, CNS Healthcare
Memphis, Tennessee, United States
InSite Clinical Research, LLC
DeSota, Texas, United States
Zillan Clinical Research
Houston, Texas, United States
AIM Trials
Plano, Texas, United States
Cedar Clinical Research
Murray, Utah, United States
Inner Space Research, LLC
Orem, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Stephen Adams
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Danielle Recasens
Role: primary
Julia Salmon
Role: primary
Role: primary
Amber Tannahill
Role: primary
Morgan Hecker
Role: primary
Katherine Prowse
Role: backup
Role: primary
Jennifer Rhode
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Tiana Tangulu
Role: primary
Tera Wolf
Role: backup
Related Links
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Apply for Trial Here
Other Identifiers
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CYB003-002
Identifier Type: -
Identifier Source: org_study_id