Study of One Oral Dose of CYB003 to Explore Effects on Brain Activity in Adults With Major Depressive Disorder and Moderate to Severe Anxiety

What this Trial Is About

This research aims to understand how psychedelics might help treat symptoms of depression and anxiety in people diagnosed with major depressive disorder MDD experiencing moderate to severe symptoms. The study focuses on CYB003, a synthetic form of psilocin the active part of psilocybin, to explore its effects on brain activity and connectivity, as well as symptom changes. It is a randomized, double-blind, placebo-controlled Phase 2 trial involving adults aged 21 to 65 with ongoing depressive and anxiety symptoms despite current antidepressant treatments. Participants will be randomly assigned to receive one oral dose of either 16 mg of CYB003 or a placebo orange drink. Psychological support is provided before, during, and after the dosing session. Assessments occur at baseline, 2 days, and 21 days after dosing and include brain scans EEGEMG and MRI, clinical rating scales for depression and anxiety, cognitive tests, questionnaires about psychedelic effects, and blood tests for biomarkers. During the study, participants will complete interviews and self-report questionnaires to track symptom changes. Brain activity and connectivity are measured using functional MRI and EEG. Safety and symptom effects are monitored through clinical scales such as MADRS and HAM-A. The study measures changes at 24 hours and 21 days after dosing to understand short- and longer-term effects. The trial is expected to continue until November 2028, with participant involvement spanning the dosing and follow-up assessments.

A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety