Basic information

Investigator: prof. MUDr. Jiří Horáček, Ph.D., FCMA
Main recipient: National Institute of Mental Health (NIMH)
Co-recipient: Masaryk Memorial Cancer Institute
Research period: 1/5/2024 - 31/12/2027
Total budget: 18,244,000 CZK
Budget NIMH: 15,061,000 CZK
Supported by: Czech Health Research Council (AZV ČR)

Annotation

Depressive symptomatology in cancer patients represents a serious comorbidity affecting the quality of life and the course of the primary cancer diagnosis. Commonly available pharmacological and nonpharmacological treatments do not provide sufficient and timely relief. Therefore, there is a need to test new pharmacological options, such as psilocybin and ketamine assisted psychotherapy, for which a rapid to immediate onset of antidepressant response has been demonstrated. The study (EudraCT number: 2020- 005037-32) is a phase II clinical trial to verify the antidepressant effect of a single fixed dose of psilocybin (20 mg) in cancer patients with comorbid depression. The effect of psilocybin will be compared against ketamine (a rapid antidepressant effect) and active placebo (midazolam, no antidepressant effect) in a doubleblind, three parallel arrangement. A total of 60 patients will be randomized to each group in a 1: 1: 1 ratio. The result of the study will be to verify the efficacy and safety of rapid antidepressant treatment in cancer patients.

PROJECT OBJECTIVE
Primary objective: To evaluate the efficacy of psilocybin and ketamine (in comparison with active placebo midazolam) in the treatment of depression comorbid to cancer at 4 weeks (day 28) after its administration. Secondary objective: To evaluate the onset and duration of the antidepressant effect of psilocybin and ketamine (in comparison with active placebo midazolam). Exploratory objectives: To evaluate the effect of psilocybin and ketamine on the quality of life and well-being and nonspecific anxiety. To elucidate the mediators of the clinical effect derived from the analysis of the intensity and phenomenology of the acute psychological effects of the psilocybin a ketamine. To elucidate the interaction between standard antidepressants use and antidepressant effect of psilocybin a ketamine. Safety assessment: To evaluate the effect of psilocybin and ketamine on acute and persisted safety measures (vital signs, suicidality, somatic and psychological adverse events).