TGA approves psilocybin and MDMA for use in treating depression and PTSD

Australia’s medical regulator has approved the use of psychedelics to treat some mental health conditions, making the country one of the first in the world to “officially recognise MDMA and psilocybin as medicines”.

Key points:

International studies looking at psychedelics’ ability to treat mental health conditions have shown promising results, however experts have urged caution and called for more research into their long-term effects before making them a mainstream treatment.

From July 1, authorised psychiatrists will be allowed to prescribe MDMA — the active ingredient in party drugs such as “ecstasy” or “molly” — to treat post-traumatic stress disorder (PTSD).

They will also be allowed to prescribe psilocybin, a compound found in psychotropic “magic” mushrooms, for treatment-resistant depression.

The TGA said the decision addressed the “lack of options” for people with some mental illnesses that did not respond to other treatments.

“There is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression and post-traumatic stress disorder,” the TGA said on its website.

“Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions.”

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About one in three people with depression have “treatment-resistant depression”, meaning the current stable of gold-standard treatments like SSRIs and psychology do not work.

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The TGA stressed that the drugs had only been approved for use under controlled medical settings by authorised psychiatrists.

All other uses of psilocybin and MDMA will remain prohibited.

Trials promising but experts stress more research needed

There are no TGA-approved medicines containing MDMA or psilocybin available in Australia, meaning authorised psychiatrists will need to supply patients with “unapproved” medicines containing those substances.

The TGA said the decision to allow the treatment was made because for some patients, the benefits of being treated with these substances under a psychiatrist’s supervision outweighed the risks.

“Clinical trials have shown promise when they (MDMA and psilocybin) are used in combination with psychotherapy conducted in strictly controlled medical settings,” the regulatory body said.

Psilocybin, the active ingredient in magic mushrooms, has been studied for its potential psychiatric benefits.(ABC South West: Roxanne Taylor)

A study by John Hopkins Health, published in the Journal of Psychopharmacology last year, found that under carefully controlled settings, psilocybin-assisted psychotherapy was a promising approach that could “lead to significant and durable improvements in depression”.

The researchers noted the study was done in a clinical setting with just 27 participants, and said people should not try using magic mushrooms to treat depression on their own.

A separate review of 14 studies published in 2020 found there was not enough evidence to support approving psychedelic substances for widespread use, but said further research was “definitely” warranted.

While some researchers and clinicians celebrated the TGA’s decision, others warned far more research was needed before broadly prescribing the treatments.

Swinburne University cognitive neuropsychologist Susan Rossell said “substantial further research” needed to be done to assess which conditions were best treated with the drugs and which formulations would best serve patients.

“We’ve got no data on long-term outcomes at all, so that worries me a lot,” she said.

Professor Rossell recently launched Australia’s biggest research trial examining the use of psilocybin for treatment-resistant depression.

The trial aims to follow a group of 160 people over the course of 12 months after treatment with psilocybin, assessing how effective the substance is and how long its effects last.

“Do the initial very promising positive effects of reductions in depression last?” Professor Rossell said.

“And if they don’t last, when do people relapse?

“And are there any other issues that happen over the 12 months after they’ve had this intervention?

“[That is] really important data to have.”

Richard Bryant from the School of Psychology at the University of NSW also urged caution, saying scientists did not know how MDMA compared to existing, evidence-based treatments for PTSD that were “cheaper and simpler”.

“The science is at a point where we can say it is too early to be prescribing MDMA for PTSD patients,” he said.

“Instead, we should be investing in research to understand how MDMA can be used in relation to proven treatments.”

Decision offers hope to ‘thousands’

Other experts have described the TGA’s decision as a step forward that will make it easier to research psychedelic treatments.

Supporters of the TGA’s decision have been waiting for psilocybin to be recognised as a medicine.(Supplied: St Vincent’s Hospital)

Senior lecturer at Edith Cowan University Stephen Bright said the decision made “Australia the first country in the world to officially recognise MDMA and psilocybin as medicines”.

“Recognising that illegal drugs like MDMA and psilocybin have medical utility is an important step in drug policy reform, however, the safe provision of these treatments requires extensive training, which is why they have been limited to clinical research in Australia to date,” he said.

Mike Musker, an enterprise fellow in the Mental Health and Suicide Prevention Research and Education Group at UniSA Clinical & Health Sciences, said the decision offered hope to “thousands of people across Australia where traditional medications have not helped their condition”.

“Access to psilocybin and MDMA in Australia has been long awaited for both research and treatment,” he said.

“There are many people in the community experiencing PTSD and depression, particularly army veterans and people who have worked in emergency services, where standard psychiatric drugs have not worked and offer no relief.”