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Psilocybin Clinical Trials

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

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Id: ACTRN12619001225101

Organisation Name: St. Vincent's Hospital Melbourne

Overal Status: Not yet recruiting

Start Date: 27/09/2019

Brief Summary: 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.

  • Australia
  • Depression in terminal illness (any palliative condition including malignant and non-malignant terminal illnesses)
  • Anxiety in terminal illness (any palliative condition including malignant and non-malignan terminal illnesses)

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