Psilocybin Versus Ketamine in Treatment-Resistant Depression
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).
Timeline
- Start
- 2021-05-01
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | 200 mg | Oral |
| Comparator | Ketamine | Small molecule | 250 mg | Oral |
| Comparator | Midazolam | Small molecule | 5 mg | Oral |
| Subject | Psilocybin | Other / unclassified | 20 mg | Oral |
| Subject | Psilocybin | Other / unclassified | 25 mg | Oral |
Indications
No indication recorded.