Open-label interventional parallel study (n=96) comparing depressed patients treated with esketamine (Spravato) with healthy volunteers using fMRI emotional tasks, behavioural measures and biological profiling.
This non-randomised parallel study will compare depressed patients receiving esketamine with healthy controls using fMRI emotional tasks and pupillometry to investigate neural circuits underlying negative emotional bias.
Assessments include tasks using validated image banks, behavioural measures of emotional valence, anatomical and functional MRI (~90 min), and biological investigations of immuno-inflammatory profiles and mRNA editing; clinical response measured by MADRS at 4 weeks with early change after dosing evaluated as a predictor.
Depressed patients receiving esketamine (Spravato) with neuroimaging, behavioural tasks and biological investigations.
Esketamine (Spravato) administered as decided by treating psychiatrist; local clinical dosing protocol.
fMRI with emotional task and pupillometry (~90 min; task ~20 min).
Behavioral task with emotional facial expressions (≈10 min).
Biological investigation: immuno-inflammatory profiling and analysis of 8 mRNA editing variants.
Healthy volunteers undergoing the same imaging, behavioural and biological assessments (no esketamine).
fMRI with emotional task and pupillometry (~90 min).
Behavioral task with emotional facial expressions (≈10 min).
Biological investigation: immuno-inflammatory profiling and mRNA editing analysis.