Four new NHS sites across England have signed up to deliver the EMBRACE trial, allowing more people the opportunity to take part in research into an investigational medication for major depressive disorder (MDD).
Depression affects millions of people worldwide. While antidepressant medicines help many, some people continue to experience symptoms despite treatment.
The EMBRACE clinical trial is exploring whether an investigational psychedelic medication, combined current antidepressant use and psychological support, is effective in reducing symptoms of MDD.
The study has now opened in:
- Cambridge – Cambridgeshire and Peterborough NHS Foundation Trust and Cambridge University Hospitals NHS Foundation Trust
- London – Centre for Mental Health Research and Innovation at South London and Maudsley NHS Foundation Trust
These sites are in addition to 5 existing locations in Doncaster, London and Reading.
The investigational study medicine, called CYB003, is similar to psilocin, the active ingredient found in Psilocybe mushrooms.
Psychedelic substances, at certain doses, may cause an altered state of consciousness, unique thoughts and changes in senses, such as hearing, seeing, tasting and/or smelling things that are not real (hallucinations).
Researchers want to understand whether combining CYB003 with psychological support can help people who don’t feel content with their current antidepressant medication to reach deeper into their thoughts, promote healing and reduce depressive symptoms.
Adults with MDD may be eligible to take part. People interested in joining will go through a screening process to determine whether the study is suitable for them. Participation in the study is expected to last around four and a half months.
CYB003 is still an investigational medication and has not yet been approved. In the study, participants will receive two doses overall of either CYB003 or a placebo, given three weeks apart under controlled conditions with psychological support.
Researchers hope the findings from EMBRACE will provide important evidence about the safety and effectiveness of this treatment approach.
EMBRACE is funded by HELUS Pharma and supported by the National Institute of Health and Care Research Mental Health Translational Research Collaboration (MH-TRC) Mission.
Dr Mourad Wahba, Consultant Psychiatrist at Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and Honorary Senior Clinical Lecturer at Newcastle University is the Chief Investigator of the study.
Dr Wahba said: “Psychedelic therapy has usually meant tapering off antidepressants, which came with its own problems. The EMBRACE trial allows us to avoid this by supporting patients to remain on their antidepressant medication as they take part in the study.
“The opening of four new NHS sites is an important milestone as it means more people across the country may be able to participate in this trial, especially as all NHS sites are part of the MH-TRC Mission Mood Disorder Network which is expanding its reach. I’m honoured to be playing a part in delivering this international trial alongside my friends and colleagues from the across the UK.
“We are grateful to the participants who are considering taking part in this research. Their involvement is vital in helping us build the evidence needed to determine whether this approach could play a role in supporting people with major depressive disorder in the future.”
People interested in learning more about the study, including eligibility criteria and participating sites, can visit the EMBRACE trial website.
