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
Visit trial
Status Active, not recruiting
Results Published No
Start date 23 January 2020
End date 31 October 2023
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 35
Sex All
Age 18- 85
Therapy Yes

Trial Details

This trial aims to investigate the use of psilocybin (a psychedelic compound) in conjunction with psychotherapy for the treatment of anxiety and depression in terminally ill patients. Who is it for? Adults aged between 18-85 years with a life threatening illness and currently under the care of a specialist physician are eligible for the study. Criteria for prospective participants includes psychological distress that was brought on by their life-threatening illness. Study details Participants will be rigorously screened, throughly prepared and supported throughout the treatment with two specialist clinicians present at all times throughout the treatment. Participants will be randomly allocated (50/50 chance) to either receive the active medication (Psilocybin 25mg) Arm 1 or a placebo (Niacin 100mg) in Arm 2. The medication or placebo will be taken once in the first arm of the study and have psychotherapy sessions with a health professional before, during and after the dose of medication/placebo. The next dose is 7 weeks later, where all participants will take the active drug, Psychotherapy sessions will take place before, during and after. All participants are followed for 26 weeks following the second dose and will be involved in interviews and questionnaires throughout the study period. Participants are followed up for 26 weeks after the second dose to ensure that we examine all changes that continue after treatment. Questionnaires and interviews are conducted throughout the study to fully understand the impact of the treatment and to monitor for safety. It is hoped that this research could potentially offer a new treatment for terminally ill patients experiencing depression and anxiety, and hopes to alleviate psychological suffering at end of life.

NCT Number ACTRN12619001225101

Sponsors & Collaborators

St Vincent's Hospital Melbourne


Data attribution

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