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 II trial (n=160) compares three 25 mg psilocybin sessions vs two 25 mg psilocybin + one placebo session vs three placebo sessions, all paired with preparatory and integrative psychotherapy for treatment-resistant depression.
Details
Randomised, parallel-group Phase IIb trial enrolling 160 participants with treatment-resistant major depressive disorder to compare two versus three dosing schedules of 25 mg oral psilocybin administered under clinical supervision alongside structured psychotherapy.
Each participant receives preparatory sessions (two), three supervised dosing sessions (weeks 1, 5 and 18) of 6–8 hours, and integration sessions (three) after each dose; primary outcome is change in MADRS after the second dosing session and at 3-month follow-up.
Psychotherapy is delivered face-to-face by a trained co-therapist dyad (a medical practitioner and a psychologist) using supportive, largely non-directive approaches; medication tapering prior to baseline is required where appropriate.