Zpráva o průběhu klinického hodnocení PSIKET_002CZE 22.7.2022-21.7.2023
| Title in English | Report on the progress of the clinical evaluation PSIKET_002CZE 22/07/2022-21/07/2023 |
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| Authors | |
| Year of publication | 2023 |
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| Web | PSIKET |
| Description | Clinical trial 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. This report summarizes data from the first year of the study, including safety data. |