A ‘raft of unanswered questions’ remain as Australia’s first psychedelic therapy clinic opens | Health

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 July, psychiatrists have been authorised 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.

Australia became the world’s first country to legalise the medical use of psychedelics when the Therapeutic Goods Administration (TGA) announced in February 2023 that the substances would be down scheduled, contrary to its previously stated position. In commentary published in the Australian and New Zealand Journal of Psychiatry, some neuropsychologists and neuroscientists said they feared the decision was driven by the influence of lobby groups instead of health experts and evidence.

But the decision has allowed Clarion Clinics to open the first dedicated facility for prescribing the drugs, headed 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 its first week, Sundram said. But he acknowledges that while there is some evidence from clinical trials to support the TGA’s decision, gaps remain in the medical understanding of the treatment.

“It would be fair to say that there’s still a lot that we need to learn and understand about these agents and how they work, what patients are suitable and what conditions are amenable to these sorts of treatments,” he said.

“We are taking a very cautious approach to this because of the aforementioned lack of data about who is suitable … there’s so much that’s not known as yet.”

What does psychedelic therapy look like?

To access the therapy at Clarion Clinics, patients need to meet the clinical diagnosis for post-traumatic stress disorder or treatment-resistant depression, and have already tried an approved treatment which has not worked.

Patients complete an online medical screening and, if they are on medication, may need to wean off it before being prescribed either MDMA or psilocybin.

They then meet with 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 potentially being treated. The process of taking the medication is explained to them.

Then the dosing session occurs, with the patient arriving early in the morning, taking the medication after an introduction, and spending the duration of the experience – a few hours, depending on the person and the two medicines – with two therapists.

After the medication wears off, the patient debriefs 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.

“Everybody gets focused on the dosing sessions, but actually the dosing sessions are only two days … and then the rest of the time over the six months initially, and then the nine months altogether, is the psychotherapy,” Sundram said.

“The medicines are there just to assist and facilitate the therapy – they themselves are not therapy. It’s a mechanism, which allows the patient to be able to think through and to experience, memories, issues, problems that in conventionally, they wouldn’t 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 left the group with only five months to develop guidelines to help psychiatrists prescribe and provide the therapy safely, in what remains a “rather unknown and undefined area”.

Harvey says the evidence has not shifted since the steering group carried out a systematic review of psychedelic treatments for the TGA.

That review found more research was needed before the drugs could be safely recommended, Harvey said.

“The evidence for the MDMA [in treating] PTSD is marginally better than the evidence for psilocybin for treatment-resistant depression, that is the one that has the slimmest [amount of evidence to support it],” Harvey said.

Prof Susan Rossell, a cognitive neuropsychologist from Swinburne’s Centre for Mental Health, is the lead researcher on Australia’s biggest research trial of psilocybin’s effectiveness for treatment-resistant depression.

“The psilocybin is what really concerns me,” she said.

“There actually isn’t a good evidence base for psilocybin-assisted psychotherapy. It’s growing and it’s promising, but it’s not as clearcut as the [evidence supporting] MDMA.”

Rossell said of the couple of thousand of cases in the world that have had psilocybin-assisted psychotherapy in major depressive disorder, some people improve, some don’t 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 could actually leave them with a post-traumatic stress disorder, which they didn’t have in the first place. And this is one of the reasons why when I was saying safety of screening people [is paramount] – really making sure that, that we don’t let people in who are vulnerable.”

It’s thought psilocybin doesn’t suit people who have histories of extensive trauma, she said.

Dr Adam Bayes, a psychiatrist and researcher of psychedelics at the Black Dog Institute, said the TGA decision “makes the case for doing more research and understanding these medicines even more powerful.”

Bayes said data is needed to answer the “raft of unanswered questions” including which patients are most likely to respond to the treatment; whether treatments can be combined; and length of efficacy .

Bayes said in trials patients have to come off all their medications, which is not possible for many patients with severe depression – so the question of whether it is also possible to stay on a medication and have psilocybin is important.

It is hoped the patients who receive treatment at Clarion can help answer some of these questions. Sundram said patients on entry would be asked for their consent to collect evaluation data to potentially publish results in scientific journals.

A $24,000 price tag

On its website, Clarion Clinics states the full treatment package costs a maximum of $24,000 with possible reductions through Medicare.

The psychotherapy component accounts for approximately 85% of the cost, Sundram said.

Although there is no subsidy through Medicare or the Pharmaceutical Benefits Scheme , the clinic estimates a quarter of the cost could be reimbursed through existing items such as psychiatric assessment and psychotherapy sessions, depending on individual circumstance.

Rossell says the high cost “… speaks to the fact that the lobby groups didn’t really think this through” 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 right research has been published,” she said.

In her research, Rossell said there are health economists tracking patients to tell the PBS how much the trial has saved. “That’s 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 offered by Clarion, Harvey said.

“But there are many other treatments that people can explore – and should have explored before they came to this option,” he said.

“This is not the first line treatment for people with either PTSD or treatment-resistant depression. People should not take away the message that ‘you’ve been diagnosed with PTSD – it’s going to cost you $25,000 for your treatment’.”