Clinical Trials
Clinical trials are carefully designed research studies that help us understand how new treatments can improve health. These studies look at how well a treatment works and how it supports people living with specific conditions. Volunteers in clinical trials play a vital role in advancing medical knowledge and shaping better care options for the future.
Why take part in a clinical trial?
Every treatment available today was made possible by people who volunteered to take part in clinical research. Joining a trial gives you the chance to contribute to important medical progress, help others and potentially access new treatments.
Introducing the EMBRACE clinical trial
The EMBRACE trial is a research study looking into a new approach for treating Major Depressive Disorder (MDD). It explores how combining an investigational psychedelic substance with psychological support, while continuing your current antidepressant may help reduce symptoms of depression.
There’s growing interest in how psychedelic substances could play a role in mental health treatment. The study drug being investigated is similar to psilocin, a naturally occurring compound. At certain doses, psychedelic substances can create a temporary shift in consciousness and perception, often leading to new ways of thinking and feeling.
This trial is designed to understand whether these effects, when paired with professional psychological support, could help people living with MDD explore deeper thought patterns and support long-term healing, especially for those who haven’t experienced full relief from their current treatment.
EMBRACE is a Phase 3 clinical trial, meaning the study drug has already been tested in earlier trials to assess its safety and appropriate dosing. These earlier phases included healthy volunteers and people living with MDD. Phase 3 trials involve a larger number of participants and aim to understand how effective the treatment may be in real-world conditions.
By joining a clinical trial like EMBRACE through Brain and Mind Hub, you’re helping to expand our understanding of MDD and explore the potential of new treatment options.
Could EMBRACE be right for you?
Major Depressive Disorder is a common condition that can affect how you feel, think and function in daily life.
While there are approved medications available, many people experience side effects or find they don’t fully relieve symptoms. Antidepressants often take several weeks to start working, and may need to be taken long-term.
This trial aims to explore whether combining a new investigational treatment with existing medication and therapeutic support can offer greater relief for people who haven’t found success with standard treatments alone.
About the EMBRACE clinical trial
What treatment is being studied?
The EMBRACE trial is exploring a psychedelic medication, used together with psychological support and your current antidepressant, to see how effective it may be in easing symptoms of Major Depressive Disorder (MDD).
Interest in psychedelic therapy for mental health has grown in recent years. The study drug, which is similar to psilocin, may temporarily alter perception, emotions and thinking. This trial aims to understand whether these effects, combined with professional therapeutic support can help individuals who haven’t found relief through standard antidepressant treatment.
Participants will receive support from a trained therapist using the EMBARK model for MDD, with sessions before and after each dosing day. Two trained therapists will be present during dosing sessions.
The study drug is taken in capsule form during two in-clinic sessions, spaced about three weeks apart. Each session may involve several hours of sensory or emotional changes, with continuous support provided throughout. After dosing, a trusted adult must accompany participants home.
What's involved in taking part?
Participation runs for approximately 4.5 months and includes:
- 8 in-person clinic visits
- 8 remote video check-ins
- 9 psychological support sessions (held in-person or online)
Most appointments are around 2 hours, with dosing sessions lasting about 8 hours.
Participants are randomly assigned to receive either the study drug (8 mg or 16 mg) or a placebo, both alongside full psychological support. The placebo looks the same but contains no active ingredients.
This is a double-blind trial, which means neither you nor the research team will know which treatment you’ve received, helping ensure the results are unbiased and scientifically valid. Throughout the trial, you’ll continue taking your regular antidepressant as prescribed.
What happens after the trial?
If eligible, participants may be invited to take part in a long-term extension study. In this phase, everyone will have the opportunity to receive the study drug with psychological support. There will be no placebo group and it will extend across a period of about 43 weeks.
Double-blinded controlled trials are considered the gold standard of evidence in medical research.
EMBRACE Trial Timeline
The EMBRACE clinical trial takes place over several stages, with regular check-ins to support your wellbeing throughout.
STEP
Screening Period (up to 6.5 weeks)
During this stage, the clinical team will do a range of checks to ensure the trial is a good fit for you.
You'll also take part in three pre-dose psychological support sessions to help prepare for your first dosing session.
STEP
Treatment Period (6 weeks)
This stage includes two dosing sessions, spaced about three weeks apart. You’ll receive either the study drug or a placebo capsule, alongside full therapeutic support.
Each dosing day lasts around 8 hours, with trained therapists by your side to ensure your comfort and safety.
In the three weeks following each dose, you’ll complete:
- Three post-dose psychological support sessions
- Three remote visits
- One clinic visit
STEP
Follow Up Period (6 weeks)
To check in on your progress, you'll attend:
- Two clinic visits
- Two remote visits
These sessions are designed to monitor your mental health and overall wellbeing after the treatment period ends.
Visit Activites
Throughout the trial, you’ll be supported by a team of healthcare professionals. Each clinic visit may include some or all of the following activities:
Health Review
Discuss your overall health, existing conditions and any medications.
Mental Health Review
Talk about your symptoms and recent mood changes.
Dosing
Take a capsule of either the study drug or placebo.
Physical Exam
A general health check by our clinician.
Vital Signs
Monitoring your blood pressure, heart rate and temperature.
Blood and urine tests
Routine tests to assess your health and screen for certain substances.
Electrocardiogram
An electrocardiogram to record your heart’s electrical activity.
Breathalyser test
A quick check for alcohol in your system at select visits.
Questionaires
Surveys about your mood, anxiety, and quality of life.
Remote Services will include:
Some visits will be done via video call, and may include:
- Health check-ins
- Questionnaire-based assessments
EMBRACE Clinical Trial FAQ’s
Why are clinical trials important?
Clinical trials help researchers learn whether a new treatment may be more effective than current options. They also help identify possible side effects. Thousands of people around the world take part in clinical trials each year, and every medication available today was once tested in one.
Is participation voluntary?
Yes, taking part in any clinical trial is completely voluntary. You can choose to withdraw at any time, and this will not affect your access to future medical care.
What is informed consent?
Before joining a clinical trial, you’ll be asked to give your consent. This means you understand all aspects of the study and agree to take part. It’s important you feel informed and comfortable with your decision. You should never feel pressured and you're encouraged to discuss your options with family or friends before deciding.
How is the study drug given?
The investigational study drug (or placebo) is taken as a capsule at the trial site during your scheduled dosing sessions.
Each session will last around eight hours. If you need more time before leaving the clinic, the trial team will stay with you until you’re ready. During the session, you may experience changes in perception, emotion or thinking. Two trained session monitors will be present the entire time to support you and ensure your safety.
After each session, you’ll need to be accompanied home by a trusted adult, as you won’t be able to drive or use machinery for at least 24 hours. Dosing sessions will be audio and video recorded for safety monitoring.
How many visits are required?
You’ll attend at least eight in-person visits at your chosen trial site and eight remote video appointments over the course of approximately four and a half months.
What happens during psychological support sessions?
A licensed therapist, trained in the EMBARK support model for MDD, will guide you through several sessions before and after each dosing day. The therapist and a second monitor will also be with you during the dosing sessions for ongoing support and safety.
Each pre- and post-dose session lasts around 90 minutes. At least one pre-dose session must be in-person; the others can be either in-person or via video call.
The post-dose sessions are designed to help you reflect on and process your experience during the dosing session.
Are there risks involved?
All medications carry some level of risk, and the investigational drug in this trial is no exception. Some participants may experience side effects, or their symptoms may not improve. If you notice any changes in your health or have concerns, it’s important to speak with your trial doctor.
What happens after the trial ends?
Once your part in the trial ends, you will no longer receive the investigational study drug, even if you found it beneficial. You’ll return to care with your usual treating doctor, as before the trial.
If eligible, you may be invited to join a long-term extension of the trial. In this phase, all participants will receive the study drug with psychological support (no placebo group), after meeting specific requirements. This extension lasts around 43 weeks.
All data collected during the trial is anonymised and analysed by a scientific team. A report is then prepared for the appropriate regulatory bodies. Your identity will remain private, your name will not appear in any published results.
Do I have to pay anything?
There is no cost to take part in the trial. The investigational drug, along with all required tests and procedures, are provided free of charge. However, the trial does not cover the cost of any medications or treatments unrelated to the study. You may be reimbursed for reasonable travel and meal expenses for each trial visit.
What if I change my mind?
You are free to withdraw from the trial at any point, without needing to give a reason. This will not impact your access to ongoing medical care.
How is my personal information protected?
Your personal health information will be kept confidential. If you express interest in the trial, your details will be passed to the research team at your selected site. A member of the team will contact you to see if the study is suitable.
Your personal information will never be shared outside of the trial team without your permission, unless required by law or local regulations.