Evaluation of the effectiveness of psilocybin-assisted psychotherapy in treatment-resistant depression
VANCOUVER, BC, October 13, 2021 / CNW / – MYND Diagnostics Inc., a wholly owned subsidiary of MYND Life Sciences (CSE: MYND) (OTC: MYNDF) is pleased to announce that the company’s proprietary biomarker testing technology will be a central component of a proposed clinical trial aimed at obtaining partial funds with a $ 15 million funds allocated by the Australian government.
The proposed project will directly address the desired outcomes by performing a single phase of adaptive dose research 2b clinical trial on the efficacy and safety of psilocybin-assisted psychotherapy (âPAPâ) in the treatment of people diagnosed with treatment-resistant depression (âTRDâ). MYND Diagnostics’ proprietary biomarker suite will be used in the trials to assess and then monitor blood indicators of patient response, progress, and any relapse to psilocybin treatments administered in the trials.
The project team will be led by the professor Paul Fitzgerald, from Monash University with 7 scientific collaborators from Monash University, Deakin University and the University of Sydney. Dr Fitzgerald is Director of the Epworth Center for Innovation in Mental Health (“ECIMH”) and Professor of Psychiatry at the Epworth Clinic / Epworth Health Care in Camberwell. He is a graduate psychiatrist with a master’s degree in psychological medicine and a research doctorate. Professor Fitzgerald has conducted more than 20 registered clinical trials through this program over the past two decades.
The proposed study is entitled Evaluation of the effectiveness of psilocybin-assisted psychotherapy in treatment-resistant depression and MYND Diagnostics will play a key role in the âassessâ component. If successful, it will, within 12 months of its completion, lead to a phase 3 multi-site adaptive trial to conduct this treatment until regulatory approval by the Therapeutic Goods Association (“TGA”), the Australian counterpart to Health Canada and the United States. Food and drug administration.
Major depressive disorder (“MDD”) is common and carries the greatest global burden of disease. Although there are established treatments for depression, people often do not respond to these treatments. At least 1/3 of patients with depression have an inadequate response to medications, many of whom remain persistently ill. Psilocybin is a naturally occurring psychedelic and is converted in the body to psilocin which is the psychoactive agent. The form and dose of the drug and the psychotherapeutic approach are all important considerations that will be refined during the trial.
Psilocybin has a number of characteristics that support its potential use in patients with depression. These patients often require a psychotherapeutic approach to treatment, but find it difficult to successfully engage in therapy due to impaired concentration, mood, and motivation. Psilocybin has the potential to immediately stimulate engagement in mood-enhancing therapy in addition to the direct physiological effects produced by the substance.
âWhen Dr Fitzgerald and I signed nondisclosure agreements and began discussions in May of this year, we were optimistic about the receptiveness of this trial within the Australian government regulatory framework,â said Dr Fitzgerald. Lyle Oberg MD, CEO of MYND Life Sciences. âDepression and other neuropsychiatric disorders are a plague on the human population which, unfortunately, knows no borders. As such, our proposed solutions will require international collaborations within multiple government regulatory ecosystems. We are impressed with Dr. Fitzgerald’s research and leadership in this area. space, the team he has assembled, and his eagerness to provide one of the very first opportunities to test our emerging suite of biomarker testing. “
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MYND Life Sciences, the parent company of MYND Diagnostics INC., Is a medical biotechnology drug research and development company focused on the development, diagnostics and vaccines of novel psilocybin-based drugs and neuropharmaceuticals. The Company advances pharmaceutical products through rigorous scientific and clinical trials, while diligently patenting and protecting its intellectual property. For more information and to subscribe to the Company’s mailing list, please visit https://myndsciences.com/contact/
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SOURCE Mynd Life Sciences Inc.
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