Publication details
ANNUAL SAFETY REPORT nr. 1 (Nr. 3 periodic annual assesment incl. previous DSURs) Reporting period: 22.7.2024 – 21.7.2025
| 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_002CZE study evaluates the safety data received by the study sponsor during the period from July 22, 2024 to July 21, 2025. The clinical trial is taking place in two centers in the Czech Republic. Depressive symptoms are a very common comorbidity in patients with cancer, with depressive symptoms occurring in up to a quarter of patients. It is not uncommon for patients with cancer to describe a whole set of symptoms known as existential distress. This includes depression and a wide range of other negative experiences, fears and anxieties, feelings of hopelessness, despair, demoralization, fear of death or recurrence of cancer, concerns about loss of dignity, loss of meaning in life, regret, grief, social exclusion, desire for death, and others. Depressive syndrome then worsens the quality of life of patients and contributes to the unfavorable course of the cancer itself, including lower compliance with anticancer treatment. Currently, psilocybin is one of the most widely used psychedelics in controlled clinical studies as a model substance for the psychotic process and also in the therapy of some psychological (personality disorders, depression, obsessive-compulsive disorders, addictions) and neurological disorders. When using psilocybin for treatment, we are talking about the so-called psilocybin-assisted psychotherapy. |