EMBRACE Study – CYB003 (psilocin) for major depressive disorder who are currently taking a stable dose of antidepressant medication
Aims
In this research study, CYB003 (psilocin) is being tested for use in people with major depressive disorder (MDD) who are currently taking a stable dose of antidepressant medication.
The main purpose of this study is to investigate how well two initial doses of CYB003 work to lessen the severity of symptoms in MDD within the first 12 weeks of the study and to determine the durability and long-term safety of CYB003 over approximately one year (around 56 weeks).
Methods
Our study will investigate the efficacy, safety, and tolerability of CYB003 in participants with MDD who are currently taking a stable dose of antidepressant medication.
Participants enrolled in this trial will be randomised to receive either 0mg, 8mg or 16mg of CYB003; it is double-blinded, meaning the study team nor the participant will be told which dose they will receive. After completing the first 12 weeks of the study, there will also be the potential option to participate in an Open Label Extension, where all participants could receive up to three doses of 16mg of CYB003.
Participating in the trial
If you wish to volunteer for this trial, please consider your decision carefully. There are strict inclusion and exclusion criteria the team cannot deviate from. You will be asked to attend the research facility on numerous occasions, with only some flexibility in dates. Clinical trials are not the same as receiving treatment from your doctor or therapist. We use placebos or variable doses in some of our trials.
Most people who volunteer turn out not to be eligible for a clinical trial so it’s important to be realistic about your chances of inclusion and pursue other sources of help at the same time.
Effects of Psychedelics
Psilocin's effects typically last for around six to eight hours. We only give people psychedelics in a dedicated hospital facility with support from doctors, nurses, psychotherapists and study coordinators. We don’t give people psychedelics to take home.
It isn’t possible to predict how psychedelics will affect an individual person. Clinical trials are an experiment. They are done because we do not yet know if psychedelic therapy is a safe and effective form of treatment. Therefore, your participation in the trial may come with some risks. Your condition could improve, stay the same, or worsen.
Psychedelic therapy is not a ‘reset’ for your brain and it is not a ’quick fix’. Regardless of what happens, it’s important to have the right support around you. There are limits to the extent the study team can support you, particularly out of normal office hours.
Trials Design
|
Status |
Open to recruitment |
|
Participants |
Adults |
|
Clinical area |
Major Depressive Disorder |
|
Intervention |
Psilocin |
|
Recruitment period |
Jan 2026-Feb 2027 |
|
Contact | |
|
Funder |
Helus Pharma |
|
Sponsor |
Helus Pharma |
Funding
Amount: -
Period: January 2026 - February 2027