Basic informations

Investigator: prof. MUDr. Jiří Horáček, Ph.D., FCMA
Main recipient:: National Institute of Mental Health (NIMH)
Research period: 1/11/2021 - 30/6/2022
Total budget:  871,900 CZK
Supported by: PSYRES, Czech Psychedelic Research Foundation

Annotation

A randomized double-blind study with the possibility of entering an open-label extension" (EUDRACT No.: 2020-005037-32). Realization of the study PSIKET_002CZE "Psilocybin - a strategy of rapid antidepressant response in depression comorbid with oncological disease.

Clinical evaluation PSIKET_002CZE is focused on the study of the antidepressant effect of psilocybin in a population of patients with a depressive disorder that accompanies oncological disease. In this phase II clinical trial, the effect of psilocybin is compared against the active substance 2 of ketamine (already shown in the past to have a rapid antidepressant effect) and the control drug midazolam (no antidepressant effect) in a double-blind design with three parallel groups. A total of 60 patients will be randomized to individual groups in a ratio of 1:1:1.