A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (NCT06793397) | Clinical Trial Compass
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
United States, Australia, Czechia330 participantsStarted 2025-12-10
Plain-language 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/
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Part…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing CYB003, a deuterated psilocin analog — which is a modified form of the active compound in psilocybin — so could you explain how being a 'deuterated analog' might affect how it works or how it differs from other psilocybin-based treatments I've heard about?
2Since this is a Phase 3 trial measuring depression severity using the Montgomery-Asberg Depression Scale, what does that phase mean in terms of what's already known about CYB003's safety, and are there any side effects or risks I should specifically discuss with you before considering it?
3Given that this trial involves a psychedelic-type compound, what kinds of psychological support or monitoring would be provided during and after the dosing sessions, and how might the demands of that process fit with my current work, family, or living situation?
4Before considering a trial like this, would you recommend I try one or more standard antidepressant treatments first, or does my specific situation make exploring this trial a reasonable option to discuss now?
5If I were to participate in this trial and it didn't help my depression, would joining it affect my ability to start or switch to other approved treatments afterward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montgomery-Asberg Depression Scale (MADRS)
Timeframe: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.