The TGA approved the prescription of MDMA and psilocybin (found in magic mushrooms) for certain mental health conditions. Photo: File.
A team from the ANU has developed a world-first registry to track the effectiveness, safety and further development of psychedelic drugs to be used in the treatment of serious mental health conditions.
The Therapeutic Goods Administration (TGA) has changed the classification of two psychedelic substances – MDMA and psilocybin (a compound found in magic mushrooms) – to allow them to be prescribed by authorised psychiatrists to treat post-traumatic stress disorder (PTSD) and treatment-resistant depression.
The changes came into effect on 1 July, however stage three clinical trials are still underway into the use of these substances.
As late as 2021 the TGA had rejected applications to amend the poisons regulation to allow for the substances to be used in medically-controlled environments.
The TGA explained there was emerging evidence these medicines could help people with specific mental health conditions that other medicines and therapies couldn’t treat, and that was why it had made this decision now.
“While research on psychedelic medicines is not conclusive, there are promising signs,” a statement read.
The body acknowledged in its decision regarding reclassification that there are currently no approved products containing psilocybin or MDMA that it has evaluated for “quality, safety and efficacy”.
“However, this amendment will allow authorised psychiatrists to access and legally supply a specified ‘unapproved’ medicine containing these substances to patients under their care for these specific uses,” a TGA statement said.
“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established.”
Instead of waiting for clinical trials to publish their results, ANU School of Medicine and Psychology director Professor Paul Fitzgerald and his team have decided to get ready to collect health data from patients across Australia.
Prof Fitzgerald said the approval of the use of these drugs was “slightly unusual”.
“Neither have been supported by stage three clinical trials … but there’s good evidence to show they’re likely to work,” he said.
“We want to be able to demonstrate how well they work, if at all, see that they’re safe to be used outside of clinical trials and to understand them better as they’re used in the future.”
He explained that there was a large number of people suffering from depression or PTSD for whom traditional treatments and therapies weren’t working.
“Both depression and PTSD are conditions that have an enormous impact on our community, they’re very common,” Prof Fitzgerald said.
“The reality is a substantial proportion of people – one-third of people with depression and about half of people with PTSD – don’t get better through the existing treatments we have.”
There’s no regulated use of psychedelics from which researchers can build a registry like this one, so a lot of it has been built from scratch.
Prof Fitzgerald said it would run parallel to the clinical trials to capture those people who might not be eligible for those studies.
He explained some trials could be more restrictive in terms of the eligibility for people to participate, and therefore the impacts on key groups of people could be missed.
For example, a trial could exclude a person with depression if they also had PTSD or alcohol-dependency issues.
Prof Fitzgerald said the registry would provide more realistic data about the impacts of the treatments.
“When treatment translates into the real world … you don’t always know if the same benefits will be seen,” he said.
“The registry allows us to get real-world data to understand if it is as safe and beneficial as in the trials … the registry should also give us a better idea of whether the use of these substances as a potential therapy will be more successful in some patients than others.
“We really want to understand how the treatment is working, not just whether it is working,” he said.
It’s hoped the registry will have hundreds, or even thousands, of patients opt in to be monitored through the registry, with plans to run it for years to come.
The ANU’s registry to inform the use of psychedelic-based therapy for depression and PTSD is due to go live in the coming weeks. To find out more, email papregistry@anu.edu.au.
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