Ketamine molecule:

Image from PubChem

Ketamine Clinical Trials


Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression


To see complete record on clinicaltrials.gov, please visit this link

Id: NCT05383313

Organisation Name: National Institute of Mental Health, Czech Republic

Overal Status: Recruiting

Start Date: May 1, 2021

Last Update: May 20, 2022

Lead Sponsor: National Institute of Mental Health, Czech Republic

Brief 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).

Conditions:
  • Treatment Resistant Depression


Total execution time in seconds: 0.39437294006348