Psilocybin – a strategy of rapid antidepressant response in depression comorbid with cancer, a randomized double-blind study with the possibility of entering open extension

This double-blind, randomised controlled trial (n=60) investigates the rapid antidepressant response strategy (ketamine versus psilocybin) for depression comorbid with cancer.

Sponsored by the National Institute of Mental Health in Czech Republic, the trial compares the efficacy of psilocybin and ketamine with midazolam as a control substance.

The primary objective is to expand therapeutic options for such depression, aiming for a significant reduction in patients’ mental suffering. Secondary objectives include assessing safety, onset and duration of antidepressant effects, and effects on quality of life, anxiety, and other psychological factors.

Participants must be aged 18-75 with comorbid depression and cancer, meeting specific diagnostic criteria. The trial excludes individuals with certain medical conditions, substance use disorders, or inadequate cognitive function.

Primary and secondary endpoints include changes in MADRS scores and various psychological assessments over a 24-week period. This trial aims to contribute to understanding novel treatments for depression in cancer patients, potentially offering new avenues for managing their mental health.

Topic Depression
Compound Placebo Psilocybin Ketamine
Country Czech Republic
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Trial Details



Trial Number

Sponsors & Collaborators

National Institute of Mental Health
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