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.

Trial Details

Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.

Trial Number NCT06818994

Data attribution

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