Efficacy and safety of two versus three high dose psilocybin-assisted therapy sessions in comparison to a placebo for treatment resistant major depressive disorder (TR-MDD): A double blind, 3-arm Phase 2b randomised controlled trial

This double-blind, 3-arm Phase IIb randomised controlled trial (n=160) will investigate 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).

Participants, aged 18 to 65, experiencing TR-MDD will be randomly allocated to one of three arms: Arm 1 receives 3 dose-sessions of 25 mg oral psilocybin + psychotherapy, Arm 2 receives 2 dose-sessions of 25 mg oral psilocybin + psychotherapy followed by 1 dose-session of oral inactive placebo + psychotherapy, and Arm 3 (control) receives 3 dose-sessions of oral inactive placebo + psychotherapy. The trial involves face-to-face psychotherapy sessions alongside the medication, administered by trained co-therapists. Each dose session lasts 6-8 hours and occurs at specific time points.

The primary outcome measures the reduction in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) immediately after the second dosing session and at short-term follow-up 3 months after the second dosing session.

Recruitment for the trial began on 14/08/2023, with an anticipated end date for participant enrolment on 28/06/2024. The study will be conducted at Swinburne University of Technology, Hawthorn, Australia, with funding from Woke Pharmaceuticals.

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



Trial Number

Sponsors & Collaborators

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

Swinburne University of Technology
Swinburne University of Technology, located in Melbourne, Australia, is known for its focus on innovation, industry engagement, and social inclusion.

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