An open-label study of the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)

This open-label trial (n=15) will investigate the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD).

Participants will undergo two dosing sessions with 25 mg of psilocybin each, accompanied by nine non-drug psychotherapy sessions over 12 weeks.

The trial, conducted at Swinburne University in Australia, aims to assess changes in depression symptoms using various scales, including the Quick Inventory of Depressive Symptomatology (QIDS), along with secondary outcomes such as quality of life, anxiety, cognitive function, and brain activity measured through fMRI scans.

Recruitment started in August 2022 and is ongoing, with an anticipated completion date by December 2023. The study protocol and other supporting documents will be available upon request.

Topic Treatment-Resistant Depression Depression
Compound Psilocybin
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 30 September 2022
End date 31 December 2023
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 15
Sex All
Age 18- 65
Therapy Yes

Trial Details

This open-label trial will investigate feasibility and efficacy of psilocybin-assisted psychotherapy for treatment-resistant depression. Individuals will be thoroughly screened to ensure they meet all eligibility criteria before entering the trial. All participants will receive the trial treatment. The treatment consists of two psilocybin dosing sessions (second dose optional), preceded by 3 preparatory psychotherapy sessions and followed by 3 integrative psychotherapy sessions. Participants will be under the care of a specialist team of two psychotherapists throughout the intervention. Participants will undergo multiple assessment sessions throughout the trial and there will be a long-term follow up assessment 20 weeks after the second dose. Where possible, assessments will be conducted via online surveys. Some assessments need to take place at the study site; these will be at baseline, 1 day, 3 weeks, and 20 weeks after dose 2. Assessments include questionnaires, cognitive and social processing tasks, fMRI scans, blood samples, and semi-structured interviews. It is predicted that this treatment will be effective in reducing symptoms of depression in those with treatment resistant depression.

Trial Number ACTRN12621001097831

Sponsors & Collaborators

St Vincent's Hospital Melbourne


Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

Data attribution

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