Reset Mind Sciences, a wholly-owned subsidiary of Little Green Pharma, has received Human Research Ethics Committee (HREC) approval for a trial investigating psilocybin-assisted psychotherapy for the treatment of resistant major depressive disorder (MDD).
The 12-month, single-centre, randomised, open-label, two-arm study will investigate the efficacy and safety of the therapy involving family members compared to standard psilocybin-assisted therapy for adults with treatment resistant major depressive disorder.
Reset Mind Sciences has stated the approval is the result of a more than 18-month development and approval process in co-operation with key clinical trial personnel from University of Western Australia and Edith Cowan University.
The trial builds on the increasing body of research globally into the use of psilocybin to treat depressive-related conditions by incorporating key family members into the preparatory and integration therapy sessions that precede and follow the psilocybin administration sessions.
The company raises that the trial has taken on added significance and relevance given the TGA’s announcement on 3 February 2023 that it had changed the classification of psilocybin within certain defined parameters for the treatment of Treatment Resistant Depression from 1 July 2023.
Reset Mind Sciences CEO, Shaun Duffy, commented: “We’re focused on testing and refining psychotherapy protocols and developing a network of clinicians with real-world experience in the administration of psychedelic-assisted psychotherapy.
“They’re our primary objectives here and we believe the work has taken on even more importance in the wake of the recent decision by the TGA.
“The trial will be one of the first psilocybin-assisted therapy trials in Australia and we trust it will contribute meaningfully to the clinical evidence supporting the use of psilocybin and other psychedelics for the treatment of chronic mental illness in Australia.
“Given we are investigating the condition allowed by the TGA for prescription of psilocybin from 1 July 2023, we anticipate the clinical evidence we obtain will be highly instructive in the treatment of patients under the new regime announced by the TGA.”
Through the trial, Reset will be testing and refining best practice psychotherapy protocols to accompany administration of psilocybin to trial participants.
Recruitment is anticipated to commence in the second quarter of 2023, will include 60 participants and will be conducted at the Harry Perkins Institute of Medical Research in Perth, Western Australia in conjunction with Fiona Stanley Hospital.
