CYB003 for Major Depressive Disorder
The EMBRACE trial is exploring a different kind of investigational medication, combined with psychological support while you stay on your current antidepressant, to learn how effective it might be at reducing symptoms of Major Depressive Disorder (MDD).
About This Clinical Trial
The investigational study medicine, called CYB003, is similar to psilocin (the active ingredient in Psilocybe mushrooms).
In recent years, there has been growing scientific interest in the potential role psychedelic medications could play in the treatment of mental health conditions.
It is hoped that the CYB003 along with psychological support may help people reach deeper into their thoughts to promote healing and potentially treat MDD.
A licensed therapist with training in EMBARK, a psychological support model for MDD, will work with study participants during several psychological support sessions before and after the dossing sessions. They, along with a second session monitor, will also attend the dosing sessions for both psychological support and safety purposes.
What to Expect
- Participation is expected to last about 4 ½ months
- There will be a total of:
- 8 clinic visits
- 8 remote visits (by video call)
- 9 psychological support sessions (can be remote or at the clinic)
- Participants will have a 2 out of 3 chance of receiving CYB003 and a 1 out of 3 chance of receiving a placebo.
- Participants will take oral doses (as capsules) at two visits about three weeks apart, both at the trial site under the supervision and support of the trial team and session monitors.
Who Can Take Part?
We are enrolling people aged 18 to 85 who:
- Have been diagnosed with MDD and don’t feel their current medication is treating their depression well enough
- Have been taking a single antidepressant medication at a consistent dose for at least 4 weeks
- Do not have any psychotic disorder, such as schizophrenia or bipolar disorder
There are other requirements which the trial team will discuss with you.
Contact Us to Learn More & See if You Qualify
Crisis Support Disclaimer
Notice: If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or text the Crisis Text Line (text HELLO to 741741).