A Mechanistic Study to Assess a Single Dose of CYB003 in Participants with Depression and Anxiety
This randomised, triple-blind, placebo-controlled Phase II mechanistic trial (n=40) will assess a single 16 mg oral dose of CYB003 versus placebo on brain activity and connectivity in participants with MDD and moderate-to-severe anxiety.
Details
This mechanistic, randomised, triple-blind, parallel-group study will enrol up to 40 participants with major depressive disorder and comorbid moderate-to-severe anxiety to receive a single oral dose of CYB003 16 mg or placebo.
Outcomes include EEG/EMG and fMRI/DWI measures of brain activity, connectivity and microstructural changes, alongside clinical scales (MADRS, HAM-A, C-SSRS), cognitive testing and patient-reported measures at baseline, Day 2 and Day 21.
Psychological support is provided before, during and after administration; biomarker sampling (Gsα-AC assay) and safety monitoring are included.