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International Clinical Trials

Improving Clinical Trial Outcomes Using AI and Automation

The speed with which psilocybin and other psychedelics have gone from pariah status to being widely seen as mental health’s next great pharmacological hope is nothing short of remarkable. To give a sense of this, in 2016, there were three entities engaged in psychedelic drug development programmes under the ‘commercial sponsor’ designation. As of mid-2020, at least 20 organisations, including large pharmaceutical companies, have either entered or invested in the psychedelic space. Most studies of psilocybin and other psychedelics to date have used high doses that reliably induce a full psychedelic experience. Although interest in the repeated use of low doses (i.e., ‘micro-dosing’) of psychedelics is intense, this strategy awaits its first formal human studies.

To highlight key study design decisions that any high-dose psychedelic drug development programme will have to face, this article examines several of the most pressing considerations in the development of psilocybin for major depressive disorder (MDD) and treatment resistant depression (TRD). This focus allows us to leverage the fact that these development efforts are further along than others in the psychedelic space and thus have had to wrestle more thoroughly with how to design and implement studies that meet regulatory licensing expectations. To date, the success of these design choices – as imperfect as they are – is reflected in the fact that the two drug development sponsors working in this area have both received breakthrough therapy designation from the FDA for these indications.

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Charles Raison, MD, is the Mary Sue and Mike Shannon Chair for Healthy Minds, Children & Families, and a Professor of Psychiatry at the University of Wisconsin-Madison, US. Charles also serves as Director of Clinical and Translational Research for Usona Institute, has served as mental health expert for CNN for many years, and hosts the ‘Health is Everything’ podcast. Charles is internationally recognised for his studies examining novel mechanisms involved in the development and treatment of major depression and other stress-related emotional and physical conditions, as well as for his work examining the physical and behavioural effects of compassion training.
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