Western Australian Clinical Trial into efficacy and safety of psilocybin assisted therapy involving family members for patients with treatment resistant major depressive disorder launched and first Trial patient scheduled for clinical visit
Screening of potential Trial participants has commenced with Trial expected to take approx 12 months to complete
Focused on development and refinement of best practice psychotherapy protocols to accompany administration of psilocybin
Sponsored by Reset Mind Sciences with leading academic and consultant psychiatrist Professor Sean Hood (University of Western Australia) as Principal Investigator
Will be conducted at Harry Perkins Institute of Medical Research in Perth, Western Australia in conjunction with Fiona Stanley Hospital
Is expected to be the first clinical trial to be conducted in Western Australia using psilocybin
Takes on heightened relevance and significance following the TGA’s decision to down-schedule psilocybin in defined circumstances for use with treatment resistant depression
Demerger of Reset Mind Sciences advancing, with Capital Raising Prospectus Offer open with Closing Date of 5pm AWST, 16 January 2024
Little Green Pharma Ltd.’s (ASX: LGP, “LGP” or the “Company”) psychedelics focused subsidiary Reset Mind Sciences Ltd (Reset) is pleased to announce the launch of its clinical Trial (Clinical Trial or Trial) into the efficacy and safety of psilocybin assisted therapy involving family members for patients with treatment resistant major depressive disorder.
The clinical Trial, anticipated to take 12 months to complete, 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.
Screening of potential Trial participants has commenced with the first clinical visit by a Trial participant scheduled.
The Trial 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. It is expected to be the first clinical trial to be conducted in Western Australia using psilocybin.
Last year, Reset received Human Research Ethics Committee (HREC) approval for the Trial which took on added significance and relevance following the Therapeutic Goods Administration’s (TGA) announcement in February 2023 that it had changed the classification of psilocybin within certain defined parameters for the treatment of Treatment Resistant Depression from 1 July 2023.2
Reset Mind Sciences Chief Operating Officer Dr Leon Warne said:
“The official launch of our clinical Trial is a key milestone in the short history of Reset Mind Sciences.
We anticipate this Trial, which will be one of the first psilocybin assisted therapy trials in Australia, will contribute meaningfully to the clinical evidence supporting the use of psilocybin for the treatment of chronic mental illness in Australia.
Our focus now is on screening and recruitment of potential participants to undertake the clinical Trial; with our first participant scheduled for their first visit to the Harry Perkins Institute of Medical Research later this month.”
The clinical therapy team conducting the Trial is led by one of Australia’s most respected psychiatrists Prof. Sean Hood as Principal Investigator and Reset Advisory Board members Dr. Stephen Bright and Ms Renee Harvey.
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