Randomised interventional trial (n=60) comparing psilocybin-assisted psychotherapy with family-member involvement versus PAP with therapists only; two 25 mg oral psilocybin sessions 3 weeks apart in adults with treatment‑resistant MDD.
This randomised controlled trial enrols adults (18–65) with treatment‑resistant major depressive disorder to test whether involving a family member in Psilocybin‑Assisted Psychotherapy improves outcomes compared with therapist‑only PAP. All participants receive two 25 mg oral psilocybin doses given three weeks apart with therapist support.
Dosing sessions require an 8‑hour fast and monitoring by two clinical psychologists plus medically qualified staff for a minimum of six hours; primary outcome assessed using MADRS/HAM‑D instruments with safety monitoring and contraception/pregnancy testing as specified.
Psilocybin-assisted psychotherapy with a supporting family member present during preparation; two dosing sessions (25 mg each) with therapist-led integration.
Two 25 mg oral capsules given 3 weeks apart; fast 8 h prior; monitored ≥6 h by therapists and medical staff.
Psilocybin-assisted psychotherapy without family member present during dosing (therapists only); same dosing schedule.
Two 25 mg oral capsules given 3 weeks apart; fast 8 h prior; monitored ≥6 h by therapists and medical staff.