NCT06793397 · Cybin IRL Limited
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
(EMBRACE)
What this study is about
The purpose of this study is to determine the effectiveness, safety and how well patients handle the treatment of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 s
Where
- Birmingham, Alabama
- Gilbert, Arizona
- Little Rock, Arkansas
- Glendale, California
- Imperial, California
- Los Angeles, California
- Orange, California
- San Juan Capistrano, California
- Santa Monica, California
- Stanford, California
- New Haven, Connecticut
- Jacksonville, Florida
And 19 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations