A first-of-its-kind patient registry in Australia will help inform the effectiveness and safety of prescribing psychedelic substances, as part of a therapeutic process, to patients with serious mental health conditions including depression and post-traumatic stress disorder (PTSD).
A world-first, the Pharmacotherapy and Psychedelic registry will be developed and led by researchers at The Australian National University (ANU).
Its aim is to collect health data from patients across the nation with the goal of improving patient care and health outcomes, and advancing health policy and research.
It follows the Therapeutic Goods Administration (TGA)’s decision to allow authorised psychiatrists to prescribe medicines containing the psychedelic substances MDMA, also known as ecstasy, and psilocybin, a compound found in magic mushrooms, to treat PTSD and treatment-resistant depression. The changes came into effect on 1 July 2023.
“There is no regulated use of psychedelics that you could build a registry around anywhere else in the world, so what we’re doing is quite different and novel and as a result we’re having to come up with a lot of the processes from scratch,” Professor Paul Fitzgerald, Director of the ANU School of Medicine and Psychology, said.
“Evidence of the efficacy of MDMA and psilocybin is rapidly emerging, but their use is not yet well established.
“Gathering information around the potential benefits of these substances and how effective patients find them outside the rigid boundaries of clinical trials will be really important.
“Psychiatrists prescribing the treatment will refer patients to us, and if or when patients have provided their consent, they’ll be sent a series of questionaries. We’re interested in finding out what their experience was like, but also whether there have been any specific changes in their thinking as a result of the treatment they received.”
Professor Fitzgerald said the registry will also help determine whether there are any safety issues with the therapeutic use of these psychedelic substances in the long-term.
“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,” he said.
“We really want to understand how the treatment is working, not just whether it is working. Our aim is to eventually have hundreds, if not thousands, of patients opt-in, giving us a very rich dataset to work with.”
The registry is supported by the National Health and Medical Research Council and Mind Medicine Australia.