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.

Trial Details

This double-blind, controlled trial (n=undisclosed) investigates the antidepressant effects of psilocybin and ketamine in cancer patients with depression. The study compares the efficacy and safety of psilocybin and ketamine against midazolam as a control. Primary outcomes include changes in MADRS scores after 4 weeks, with secondary endpoints assessing various psychological and quality-of-life measures. Conducted in Czechia by the National Institute of Mental Health, the trial aims to offer new therapeutic options for cancer-related depression.

Trial Number 2020-005037-32

Data attribution

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