Psilocybin Medicine Open-Label Study (PMOS): a determination of the safety and efficacy of psilocybin-assisted psychotherapy for patients with Treatment Resistant Major Depressive Disorder (TRD) within an Australian clinical context
This open-label trial (n=50) will assess the safety and efficacy of psilocybin-assisted psychotherapy in patients with treatment-resistant major depressive disorder (TRD) in an Australian clinical setting. Participants will receive two doses of psilocybin (25mg each) alongside a structured programme of preparatory and integration psychotherapy sessions over approximately 16–18 weeks.
Details
Open-label, non-randomised Phase II study delivering two supervised 25 mg oral psilocybin doses paired with preparatory and integration psychotherapy for participants with treatment-resistant depression.
Therapy comprises three preparatory sessions, two dosing sessions (visits 5 and 9) each followed by three integration sessions; outcomes include safety, depressive symptoms (GRID-HAMD), and AE monitoring with follow-up at 4 weeks and 6 months.