The idea that magic mushrooms could be used in modern medicine may seem scandalous, but scientists are eating their words by looking at data.
Swinburne has signed a research agreement with Woke Pharmaceuticals about how psilocybin - the active ingredient in psychedelic mushrooms, could be used to treat depression.
The announcement comes as the Therapeutic Goods Administration announced plans about how psilocybin and MDMA could be used in mental health treatment.
Lead researcher Professor Susan Rossell said psychedelics have been shown to provide long-term durable benefit in a multitude of psychiatric disorders.
"Psychedelics could transform the landscape of treatments for many psychiatric disorders, including major depression," she said.
"The initial positive findings from the literature need to be pursued with large real-world trials, like the one we are conducting. Exploring the effectiveness of two or three dosing sessions will provide critical data on the sustainability of benefit and effective real-world treatment regimens of psilocybin-assisted psychotherapy for those with treatment-resistant depression."
About 160 patients will participate in a randomised controlled trial of either two or three doses of psilocybin-assisted psychotherapy versus a placebo. The psilocybin drug candidate, WP002, is formulated as a rapid release tablet by Woke Pharmaceuticals.
The primary outcome will be measured with the industry standard MADRS Depression Rating Scale behaviour. Secondary measures of wellness, quality of life, and health economic assessments will also be conducted.
With enrolment starting in mid-2023, Woke Pharmaceuticals' funding and provision of clinical material will help Swinburne to collaborate with Monash University and University of Tasmania to help people living with depression who are not treated effectively with existing medications.
Swinburne's deputy vice-chancellor research, Professor Karen Hapgood, said the trial would help better understand how to support those living with Treatment-Resistant Major Depressive Disorder to live the best life that they can.
Woke Pharmaceuticals chief executive officer Nick Woolf said the trial had two benefits; one being to help the development of and potential registration of WP002 psilocybin-assisted psychotherapy as an effective treatment approach for patients, and another being the potential economic benefits to the healthcare system and society from durable remission of depression.
Associate Professor Daniel Perkins is co-executive director of the Psychae Institute, as well as an adjunct associate professor from the Centre for Mental Health at Swinburne University.
He said the administration's decision and approach enabling psychiatrists to prescribe MDMA and psilocybin struck a "pragmatic balance" between treating people but still being overseen by regulatory bodies.
He also cited Australia isn't the first country to take sure measures; since 2014, physicians in Switzerland have been able request a permit from the Federal Office of Public Health for the clinical use of MDMA, LSD, and psilocybin, and unlike Australia this does not require ethics committee approval.
