Publication details
ANNUAL SAFETY REPORT nr. 1 PSIKET (Nr. 3 periodic annual assesment incl. previous DSURs) Reporting period: 22.3.2024 – 21.3.2025
| Title in English | ANNUAL SAFETY REPORT nr. 1 PSIKET (Nr. 3 periodic annual assesment incl. previous DSURs) Reporting period: 22.3.2024 – 21.3.2025 |
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| Authors | |
| Year of publication | 2025 |
| Type | Research report |
| MU Faculty or unit | |
| web | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004480-31/CZ |
| Description | The third periodic report for the PSIKET_001CZE study evaluates the safety data received by the study sponsor during the period from March 22, 2024 to March 21, 2025. The clinical study is a monocentric study taking place in the Czech Republic. According to the WHO, the lifetime prevalence of depression in the population ranges between 8-12%, and depression is the fourth most common cause of disability worldwide. Research into new treatment strategies, including the use of older, effective, although currently unused, treatments, is therefore absolutely essential. New treatment strategies that will enable a breakthrough in resistance and in which the onset of effects is shorter than in classical pharmacological therapy appear to be key. These are the so-called rapid antidepressant treatment strategies, among which the drug ketamine currently has a dominant position. A new strategy is the use of so-called serotonergic psychedelics, especially psilocybin. The administration of psilocybin to depressed patients appears to be a competitive alternative, the main advantage being the long-term effect after a single use. |