Australia’s first psychedelic therapy clinic opened its doors this week, charging patients $24,000 for nine months of treatment.
But even the Melbourne clinic admits there are still many unknowns about the approach.
Since JulyPsychiatrists are authorized to prescribe MDMA, commonly known as ecstasy, for the treatment of post-traumatic stress disorder, and psilocybin, found in magic mushrooms, for treatment-resistant depression.
became Australia the world’s first country to legalize the medical use of psychedelics when the Therapeutic Goods Administration (TGA) announced in February 2023 that the drugs would be descheduled, contrary to its previously stated position. In comments published in the Australian and New Zealand Journal of Psychiatry, some neuropsychologists and neuroscientists said they feared the decision driven by the influence of lobby groups instead of health experts and evidence.
But the decision allowed Clarion Clinics to open the first dedicated facility for prescribing the drugs, led by psychiatrist and chair of the department of psychiatry at Monash University, Prof Suresh Sundram.
Clarion received more than 250 expressions of interest from patients in the first week, Sundram said. But he admits that while there is evidence from clinical trials to support the TGA’s decision, there remain gaps in medical understanding of the treatment.
“It would be fair to say that there is still much we need to learn and understand about these drugs and how they work, which patients are suitable and which conditions are amenable to these types of treatments,” he said.
“We’re taking a very cautious approach to this because of the aforementioned lack of data on who is eligible … there’s so much that’s not yet known.”
What does psychedelic therapy look like?
To access the therapy at Clarion Clinics, patients must meet the clinical diagnosis for post-traumatic stress disorder or treatment-resistant depression, and have already tried an approved treatment that did not work.
Patients complete an online medical screening and, if on medication, may be required to wean before being prescribed either MDMA or psilocybin.
They then meet Sundram and undergo psychiatric and physical assessments. If they are deemed eligible for treatment, they are enrolled in the program.
The therapy begins with preparatory sessions in which patients are asked about their illness and how they see it as possible to be treated. The process of taking the medication is explained to them.
Then the dosing session takes place, with the patient arriving early in the morning, taking the medication after an introduction and spending the duration of the experience – several hours, depending on the person and the two medications – with two therapists.
After the medication wears off, the patient discusses with the therapists. They come back the next day for an integration session in which the previous day’s experiences and therapeutic insights are further discussed.
Patients usually complete one psychotherapy session each week for four weeks before their second dose.
“Everyone focuses on the dosing sessions, but really the dosing sessions are only two days … and then the rest of the time over the initial six months, and then the nine months total, is the psychotherapy,” Sundram said.
“The medicine is only there to assist and facilitate the therapy – it is not therapy itself. It’s a mechanism that allows the patient to think through and experience memories, problems, issues that they wouldn’t normally be able to do.”
The unknowns
The chair of the Royal Australian and New Zealand College of Psychiatrists’ steering group on psychedelic-assisted therapy, Dr Richard Harvey, said the TGA’s surprise announcement had left the group just five months to develop guidelines to help psychiatrists safely administer the therapy. to write and provide, in what remains a “rather unknown and undefined territory”.
Harvey says the evidence has not shifted since the steering group conducted a systematic review of psychedelic treatments for the TGA.
That review found more research is needed before the drugs can be safely recommended, Harvey said.
to newsletter promotion
“The evidence for the MDMA [in treating] PTSD is slightly better than the evidence for psilocybin for treatment-resistant depression, it is the one that has the thinnest [amount of evidence to support it],” Harvey said.
Prof Susan Rossell, a cognitive neuropsychologist from Swinburne’s Center for Mental Healthis the lead researcher on Australia’s largest research trial of psilocybin’s effectiveness for treatment-resistant depression.
“The psilocybin is what really worries me,” she said.
“There really isn’t a good evidence base for psilocybin-assisted psychotherapy. It is growing and it is promising, but it is not as clear as the [evidence supporting] MDMA.”
Rossell said that of the few thousand cases in the world that have had psilocybin-assisted psychotherapy in major depressive disorder, some people improve, some do not and they may experience anxiety about what to do next if psychedelic treatment was their last resort. About 10-20% of patients experience a “bad trip,” she said.
“It can actually leave them with post-traumatic stress disorder, which they didn’t have in the first place. And that’s one of the reasons why I said safety of screening people [is paramount] – to really make sure that we don’t let people in who are vulnerable.”
Psilocybin is not thought to be appropriate for people who have a history of extensive trauma, she said.
Dr Adam Bayes, a psychiatrist and psychedelic researcher at the Black Dog Institute, said the TGA decision “makes the case for more research and understanding of this medicine even more powerful.”
Bayes said data are needed to answer the “series of unanswered questions,” including which patients are most likely to respond to the treatment; whether treatments can be combined; and length of effectiveness.
In trials, Bayes said patients must come off all their medications, which is not possible for many patients with major depression – so the question of whether it is also possible to stay on a medication and have psilocybin is important.
It is hoped that the patients receiving treatment at Clarion can help answer some of these questions. Sundram said that patients will be asked upon entry for their consent to collect evaluation data to potentially publish results in scientific journals.
A price of $24,000
On its website, Clarion Clinics says the full treatment package costs a maximum of $24,000 with possible reductions through Medicare.
The psychotherapy component accounts for about 85% of the cost, Sundram said.
Although there is no subsidy from Medicare or the Pharmaceutical Benefits Scheme, the clinic estimates that a quarter of the cost can be reimbursed through existing items such as psychiatric assessment and psychotherapy sessions, depending on individual circumstances.
Rossell says the high cost “…speaks to the fact that the lobby groups didn’t really think about this” when they pushed the TGA to approve the treatments.
“The Pharmaceutical Benefits Scheme is never going to put psychedelic assisted psychotherapy on any of their schedules until the real research is published,” she said.
In her research, Rossell said there are health economists tracking patients to tell the PBS how much the trial saved. “This is the research that will be needed to make it cheaper for people.”
Only a “relatively small number” of people will be able to afford the current treatment Clarion offers, Harvey said.
“But there are many other treatments that people can explore – and should have explored before they came to this option,” he said.
“It is not the first-line treatment for people with either PTSD or treatment-resistant depression. People shouldn’t take away the message that ‘you’ve been diagnosed with PTSD – it’s going to cost you $25,000 for your treatment’.”
