Psychedelic prescribing to begin for PTSD and depression

The Therapeutic Goods Administration’s (TGA) decision to down-schedule MDMA and psilocybin will come into effect this weekend, allowing approved psychiatrists to prescribe psychedelic medicines for specific mental health conditions.
 
In preparation, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) has released its first guidance document on psychedelic-assisted therapy, highlighting key considerations as the specialty undergoes an extraordinary paradigm shift in the way it approaches certain mental health conditions.
 
The two medicines that will now be listed as Schedule 8 (previously Schedule 9) are MDMA and psilocybin, the psychoactive components of ecstasy and magic mushrooms respectively. MDMA has been approved for use in severe PTSD and psilocybin for treatment resistant depression.
 
However, while the move has been welcomed by some, it has also attracted controversy due to the paucity of data relating to the efficacy and safety of these medicines.
 
Professor Richard Harvey, Chair of RANZCP’s psychedelic-assisted therapy steering group, describes TGA’s decision as unexpected.
 
‘It would be very unusual for any other treatment to suddenly shift from very small clinical trials into mainstream clinical practice in this way and that’s been part of the challenge for us,’ he told newsGP.
 
The TGA’s decision was supported by six randomised controlled trials for the use of MDMA in PTSD and only two for psilocybin in treatment resistant depression.
 
Speaking on Psych Matters, Professor David Castle, Co-Director of the Tasmanian Centre for Mental Health Service Innovation, said the regulatory changes are exciting but also worrying.
 
‘I never imagined in my life I would be critical of a government agency for acting too quickly,’ he said. ‘But in this scenario the TGA actually has.’
 
Treatment with both medicines must be provided in combination with psychotherapy. However, the way in which psychedelic medicines are able to reduce the symptoms of severe PTSD and depression remains largely unknown.
 
‘The experts seem to think that it’s unlikely to be a direct pharmacological effect – it is not like psychedelic medicines are acting as some sort of magic antidepressant or anti-PTSD treatment,’ Professor Harvey said.
 
‘The best guess is that the doses given are enough to put the patient into a significant altered state of mind, and potentially in that altered state of mind, that then allows them to engage in the very intensive associated psychotherapy.’
 
Significantly altering a patient’s state of mind needs to be done in a highly controlled and safe environment, which makes the logistics and costs of psychedelic prescribing a major barrier for both treating physicians and patients. Patients must be in a supported clinical space for the duration of their sessions, which may last up to eight hours.
 
The treating team administering psychedelic-assisted therapy operate in a dyad, with at least two mental health professionals taking part in the session. The cost of treatment is estimated to be upwards of $25,000, which will be out of reach for many – especially those who suffer from chronic and debilitating mental health conditions.
 
For GPs asked about these novel therapies or to refer patients for treatment, Professor Harvey’s guidance is to ensure vulnerable patients are not taken advantage of.
 
‘We need to be very careful with the expectations around this, it is by no means a miracle treatment,’ he said.
 
‘It is probably not that different to any other treatment in psychiatry. [There is some evidence to suggest] it works very well for some patients, it might work a little bit for others, and perhaps it doesn’t work at all for perhaps the majority.’
 
Professor Harvey also advises that patients only seek treatment through a trusted treating psychiatrist.
 
‘This is not something people should be accessing on a whim of via a website, or because they think they would like to give it a go,’ he said. ‘It has to be part of long-term therapy with long term follow-up.’
 
It is likewise important for patients to be aware that self-medication with illicit substances is not supported by the evidence and is not recommended by either the TGA or RANZCP.
 
The world looks to Australia
Despite the controversies and challenges ahead, Australia is now poised lead the way in how psychiatry approaches two mental health conditions that have historically been very difficult to treat.
 
‘Whether the sector likes it or not, Australia is now at the forefront of research in this field globally, and we need to seize the opportunity,’ Professor Chris Langmead, the Deputy Director of the Neuromedicines Discovery Centre at Monash Institute of Pharmaceutical Sciences said.
 
‘Despite the profound prevalence of difficult-to-treat mental illness throughout the community, very few advancements in new safe and effective treatments have emerged over the last 50 years – this simply isn’t good enough.
 
‘My hope is that the TGA’s decision will pave the way for the development of new safe, effective and widely accessible medicines to significantly improve the lives of those living with mental illness.’
 
The RANZCP has recommended that clinical quality registries are developed in order to assist in systematic data collection and research, alongside mandated outcome measures to ensure that patients are receiving appropriate and effective mental health care.
 
The Find a Psychiatrist directory will also be updated to help patients and GPs locate psychiatrists who offer psychedelic-assisted therapy.
 
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MDMA mental health psilocybin psychedelics TGA