Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed with Advanced Stage Cancer

This open-label, Phase I trial (n=15) will assess the safety and efficacy of psilocybin (25mg) alongside psychotherapy for treating demoralization syndrome in patients with advanced-stage cancer.

The study, led by Gustavo Vazquez at Queen’s University, will enrol participants aged 18-70 who experience moderate-to-severe demoralization, a psychological condition linked to depression, anxiety, and reduced quality of life. The treatment includes six psychotherapy sessions incorporating Managing Cancer and Living Meaningfully (CALM) therapy elements, with a single psilocybin dosing session administered under supervision.

Participants with a partial response after one month may receive a second 25 mg psilocybin dose. The primary outcome is a reduction in demoralization, measured using the Demoralization Scale, with additional assessments for depression, anxiety, and suicidal ideation.

Topic Palliative Care Safety Depression Anxiety
Compound Psilocybin
Country Canada
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Queen's University
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