Swinburne Three-dose Psilocybin Assisted Psychotherapy (3PAP): a clinical trial of 2 vs 3 doses of psilocybin-assisted psychotherapy vs psychotherapy with placebo for Treatment-Resistant Depression

This randomised, double-blind, 3-arm Phase IIb clinical trial (n=160) investigates two versus three doses of psilocybin-assisted psychotherapy (25mg) vs psychotherapy with placebo for Treatment-Resistant Depression (TRD).

Conducted by Swinburne University of Technology, Hawthorn, Australia, the trial aims to assess the efficacy and safety of two versus three high-dose psilocybin-assisted therapy sessions compared to a placebo for treatment-resistant major depressive disorder (TR-MDD). The intervention arms involve psilocybin doses (25mg) administered with psychotherapy, while the control group receives placebo with psychotherapy.

The primary outcome, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), is evaluated immediately after the second dosing session (week 5) and at short-term follow-up 3 months after the second dosing session (week 17). Secondary outcomes include long-term sustainability, anxiety, quality of life, employment status, cognitive function, and more.

The trial, funded by Woke Pharmaceuticals, is currently recruiting participants in Australia (QLD, TAS, VIC), with an anticipated completion date of June 2025. The principal investigator is Prof Susan Rossell, and the study is registered on ANZCTR with the registration number ACTRN12623000667617. Ethics approval was granted by the Swinburne University Human Research Ethics Committee on 16/02/2023 (Approval number: 20236919-13556).

Topic Treatment-Resistant Depression Depression
Compound Psilocybin Placebo
Country Australia
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Trial Details



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Sponsors & Collaborators

Woke Pharmaceuticals
Woke Pharmaceuticals is an Australian biotech company developing novel psychedelic compounds.

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