Psilocybin Versus Ketamine in Treatment-Resistant Depression
Status:
Recruiting
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
Summary
The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients
with TRD versus the antidepressant inactive substance midazolam. The primary endpoint will be
the antidepressant effect on the Montgomery- Asberg Depression Rating Scale (MADRS) 24 hours
after treatment, the key secondary endpoints being the duration of antidepressant effect, the
number of responses and remissions, and the time to standard antidepressant treatment during
3 months of observation. The exploratory part of the study aims to monitor changes in the
functional brain states using simultaneous EEG / fMRI, before treatment versus 1 day and 1
week after. Based on literature data and recent data from healthy volunteers who participated
in a previous study with psilocybin, the investigator will correlate antidepressant effects
of drugs (using psychometric scales and reactions to emotionally salient stimuli (eye
tracker)) with entropy and functional connectivity measures. Finally the investigator will
explore the role of plasmatic neurobiological biomarkers in depression (BDNF, prolactin, ACTH
and oxytocin).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Mental Health, Czech Republic
Collaborators:
Czech Clinical Research Infrastructure Network Czech Health Research Council