Treatment Resistant Depression Intervention with Psilocybin-assisted Psychotherapy
Open-label, non-randomised Phase I single-group study (n=20) testing psilocybin-assisted psychotherapy (initial 15 mg oral dose, up to 45 mg) for treatment-resistant depression in patients on stable psychotropic medication.
Details
Open-label, single-group Phase I study of psilocybin-assisted psychotherapy in adults with treatment-resistant depression on stable psychotropic medication; initial dosing 15 mg oral with clinician-determined escalation to a maximum of 45 mg, 1–5 dosing sessions at least one week apart.
Therapy includes three preparation sessions and post-dose integration sessions; safety assessed via vitals (BP, heart rate, temperature) measured frequently during dosing and adverse event monitoring; mood outcomes assessed with MADRS (response ≥50% reduction; remission ≤10) with follow-up to 6 months.