Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness

This parallel-group, double-blinded, randomised controlled trial (n=35) investigates the use of psilocybin (25mg), combined with psychotherapy, for managing depression and anxiety in terminally ill patients.

Adults aged 18-85 with a life-threatening illness and experiencing psychological distress due to their condition are eligible. Participants will undergo rigorous screening and preparation before being randomly assigned to either the active medication group (psilocybin 25mg) or the placebo group (niacin 100mg). The medication or placebo will be administered once initially, followed by psychotherapy sessions before, during, and after. After 7 weeks, all participants will receive the active drug. The study period lasts for 26 weeks after the second dose, during which participants are closely monitored through interviews and questionnaires to assess the treatment’s impact and safety.

The trial aims to provide a potential new treatment approach for alleviating depression and anxiety in terminally ill patients, offering hope for improved psychological well-being at the end of life.

Topic Anxiety Depression Palliative Care
Compound Psilocybin Placebo
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

St Vincent's Hospital Melbourne


Papers

Psilocybin-assisted psychotherapy for depression and anxiety associated with life threatening illness: A phase 2b randomized controlled trial
This double-blind placebo-controlled trial (n=35) found that psilocybin-assisted psychotherapy (25mg) significantly reduced depression and anxiety symptoms in adults with life-threatening illnesses compared to an active placebo (100mg niacin), with benefits sustained at 26 weeks and improvements in spiritual well-being, quality of life, demoralisation, and death anxiety.

Data attribution

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