Introducing the APPROACH clinical trial

The APPROACH trial is exploring an investigational psychedelic medication, combined with psychological support, to learn how effective it might be at reducing symptoms of Major Depressive Disorder (MDD).

In recent years there has been growing interest in the potential role psychedelic medications could play in the treatment of mental health conditions.

The investigational study medicine, called CYB003, is similar to psilocin (the active ingredient in Psilocybe mushrooms). Psychedelic medications, at certain doses, may cause an altered state of consciousness, unique thoughts, and changes in your senses, such as hearing, seeing, tasting, and/or smelling things that are not real. Psychological support and CYB003 given together may help people reach deeper into their thoughts, promote healing, and may be effective in treating MDD.

A licensed therapist with specialized training in EMBARK, a psychological support model for MDD, will work with participants during several psychological support sessions before and after the dosing sessions. They, along with a second session monitor, will also attend the dosing sessions for both psychological support and safety purposes.