Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP in adults with treatment-resistant major depressive disorder (TRMDD)
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.
Details
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.