NCT06793397 A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
| NCT ID | NCT06793397 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cybin IRL Limited |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2027-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2025-12-10 with a primary completion date of 2027-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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/
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.
Contact & Investigator
Felix Mazer
STUDY DIRECTOR
Cybin IRL Limited
Frequently Asked Questions
Who can join the NCT06793397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06793397 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT06793397 currently recruiting?
Yes, NCT06793397 is actively recruiting participants. Contact the research team at clinicaltrialsinfo@cybin.com for enrollment information.
Where is the NCT06793397 trial being conducted?
This trial is being conducted at Birmingham, United States, Gilbert, United States, Little Rock, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT06793397 clinical trial?
NCT06793397 is sponsored by Cybin IRL Limited. The principal investigator is Felix Mazer at Cybin IRL Limited. The trial plans to enroll 330 participants.