RecruitingPHASE3INTERVENTIONAL

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

This research study, called the EMBRACE study, is investigating a new medication, CYB003, for adults living with major depressive disorder. Currently in its final stages of testing before potentially becoming widely available (Phase 3), the study wants to understand how well CYB003 works, if it's safe, and if people can tolerate it. Participants will receive either CYB003 or a placebo (a dummy pill with no active medicine) alongside their usual antidepressant treatment. Psychological support is also a part of the study. The goal is to see if CYB003 can offer an additional way to help those who haven't fully responded to their current medication.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Cybin IRL Limited

Enrolment target

330

Start

10 Dec 2025

Estimated completion

08 May 2027

Major Depressive Disorder (MDD)Depression in Adults Depression - Major Depressive Disorder Depression Disorders Depression Disorder Depression

What is this study about?

This study, known as the EMBRACE study, is exploring a new treatment called CYB003 for adults who have major depressive disorder, often simply called depression. Many people with depression take antidepressant medication, but sometimes this isn't quite enough to make them feel better. This study is designed to see if adding CYB003 to their current antidepressant treatment can make a significant difference.

The main aim is to find out if CYB003 is effective in reducing symptoms of depression, how safe it is to use, and if it causes any uncomfortable side effects. Participants will be randomly assigned to receive either CYB003 or a 'placebo' (a pill that looks identical but contains no active medicine) in addition to their existing antidepressant. This allows researchers to compare the effects of CYB003 directly.

This is a Phase 3 study, which means it's one of the final steps before a new medication might be considered for wider use. The findings from this research will help decide if CYB003 could become a valuable new option for people struggling with major depression who need additional support.

Key takeaways

Investigating a new medication (CYB003) for major depression.
Aimed at adults whose current antidepressant treatment hasn't fully worked.
Compares CYB003 to a placebo, with psychological support included.
This is a Phase 3 study, a later stage of research.
Potential benefits include access to new treatment; risks include possible side effects.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be an adult between 18 and 85 years old with a diagnosis of major depressive disorder. Your depression needs to be considered moderate to severe, and you should have already been taking an antidepressant medication at a stable dose for at least four weeks, but without quite enough improvement. Basically, your current treatment hasn't fully worked for you yet.

You also need to have a Body Mass Index (BMI) of 40 or less. If you're able to have children, specific contraception rules apply for both men and women, and you must agree to follow these throughout the study. You'll also need to be able to avoid using nicotine during study visits when you receive the dose.

The study cannot include everyone. For instance, if you have certain other medical conditions or are taking specific medications, you might not be able to participate. The research team will carefully review your health information to ensure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult between 18 and 85 years old?
Do you have a diagnosis of major depressive disorder?
Have you been taking an antidepressant but still struggle with moderate to severe depression?
Is your Body Mass Index (BMI) 40 or less?
Are you able to follow specific contraception rules if applicable?
Can you avoid nicotine during study dosing sessions?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you will receive regular check-ups and assessments by the study team. You'll continue taking your current antidepressant, and in addition, you'll receive either doses of CYB003 or a placebo. This will involve scheduled visits to a study site. You'll also be offered psychological support throughout the study. The total duration of your participation, including the treatment period and follow-up, will be explained in detail by the study team. You will need to commit to attending all scheduled appointments and following the study's instructions carefully.

Potential risks and benefits

Participating in research studies like this could offer potential benefits, such as access to a new treatment (CYB003) that might help with your depression symptoms when other treatments haven't fully worked. However, there are also potential risks; CYB003 might cause side effects, which the study team will monitor closely. You will be fully informed about these before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UAB Psychiatry and Behavioral Neurology
Verified postcode
Birmingham, United States· Recruiting
Lighthouse Psychiatry
Verified postcode
Gilbert, United States· Recruiting
Pillar Clinical Research - Little Rock
Verified postcode
Little Rock, United States· Not yet recruiting
Behavioral Research Specialists, LLC
Verified postcode
Glendale, United States· Recruiting
Sun Valley Research Center
Verified postcode
Imperial, United States· Not yet recruiting
CalNeuro Research Group
Verified postcode
Los Angeles, United States· Recruiting
ATP Clinical Research
Verified postcode
Orange, United States· Recruiting
NRC Research Institute
Verified postcode
Orange, United States· Recruiting
Inland Psychiatric Medical Group Inc (IPMG Research)
Verified postcode
San Juan Capistrano, United States· Not yet recruiting
Psychedelic Science Institute
Verified postcode
Santa Monica, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Not yet recruiting
Yale School of Medicine - Yale Program for Psychedelic Science
Verified postcode
New Haven, United States· Recruiting

Common questions

What is CYB003?

CYB003 is a new medication being tested in a research study for adults with major depressive disorder. It's similar to a natural substance but modified for study purposes.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medication but contains no active ingredients. It helps researchers compare the effects of the actual medicine fairly.

Will I know if I'm getting CYB003 or the placebo?

During the main part of the study, neither you nor your study doctor will know whether you are receiving CYB003 or the placebo. This is to ensure the study results are unbiased.

What does 'Phase 3' mean for a study?

Phase 3 means this is one of the final stages of testing a new medication before it might be considered for wider use. It involves a larger group of people to confirm its effectiveness and safety.

Where can I find more information about this study?

You can visit the study's website at https://embrace-mdd-trial.com/ to learn more about the EMBRACE study, including participating locations and how to express your interest.

How to find out more

Clinical Development

clinicaltrialsinfo@cybin.com 877-361-4003 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.