This interventional trial (n=60) will assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP/PAT) involving family members in adults with treatment-resistant major depressive disorder (TRMDD). The study will compare two groups, one where PAT involves family members and another where PAT is conducted solely with therapists.
All participants will receive two doses of 25 mg of psilocybin three weeks apart. The primary outcome will be measured using the Hamilton Depression Rating Scale (HDRS) and the Montgomery–Åsberg Depression Rating Scale (MADRS) 12 months following the last psychotherapy session.
Trial Details
Trial Number
Sponsors & Collaborators
Reset Mind ScienceReset Mind Sciences, established in 2021, is a subsidiary of Little Green Pharma, a company known for its work in medicinal cannabis. Reset Mind Sciences is focused on producing and administering the psychedelic medication psilocybin derived from its in-house cultivated mushrooms1.
University of Western Australia
The University of Western Australia (UWA) is a research and educational university. UWA's psychedelic research is connected to its alumnus Dr Shaun Duffy, a leading figure in this field in Australia.