A new clinical trial exploring the impact of psychedelic medicines on brain activity has come a step closer to fruition, after being partially funded and granted ethics approval.
The trial, expected to commence later this year, will see up to 200 participants receive a single medical dose of either MDMA or psilocybin.
The primary purpose of the project is to determine whether there are any changes in brain activity (as measured by electroencephalography) following exposure to either medical grade MDMA or medical grade psilocybin.
A secondary aim of the trial is to assess potential changes in mood, personality, beliefs and social engagement following exposure to these substances that might relate to neural changes.
Professor Paul Fitzgerald, one of the trial’s two principal investigators, said, ‘The results of this study will inform us as to whether these substances have an effect on brain activity related to cognitive and emotional processes, which continues after the medicine session, and may also provide information that can help explain how these substances have their clinical effects’.
Mind Medicine Australia (MMA) announced this week that it will partially fund the project, and that the trial has just received human research ethics approval.
‘There is a desperate need for innovation in the mental health sector, and these treatments have achieved outstanding results in overseas trials after just two to three sessions, in combination with a short course of psychotherapy,’ MMA Executive Director, Tania de Jong, said.
‘We now have the potential to help people suffering from major classes of mental illness such as depression, post-traumatic stress disorder and potentially anorexia and other eating disorders, OCD, dementia and a range of addictions.’
Participants in the trial must have completed training in psychedelic assisted therapy to take part.
They will take the medicines in small groups supported by therapists and a medical practitioner.
There is evidence to suggest that psilocybin assisted psychotherapy can help in the treatment of depression, and that MDMA assisted psychotherapy can be effective in treating post-traumatic stress disorder when used in medically controlled environments.
According to the Productivity Commission, one in five Australians had a mental illness before the current COVID pandemic.
One in eight Australians (including one in four older people) were on antidepressants (an increase of 95 per cent over 15 years).
There is evidence that these numbers have risen significantly as a consequence of the pandemic.