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. 2022 Jan;36(1):6-11.
doi: 10.1177/02698811211008567. Epub 2021 Apr 22.

Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

Robin L Carhart-Harris  1 , Anne C Wagner  2   3 , Manish Agrawal  4   5 , Hannes Kettner  1 , Jerold F Rosenbaum  6 , Adam Gazzaley  7 , David J Nutt  1 , David Erritzoe  1
Affiliations

Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

Robin L Carhart-Harris et al. J Psychopharmacol. 2022 Jan.

Abstract

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

Keywords: Real-world data; pragmatic trials; psychedelics; serotonin.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RCH is a scientific advisor to Entheon Biomedical, Synthesis, TRYP, COMPASS Pathways, Usona, Maya Health, Osmind and MyDecine. He is also Founder of the app MyDelica (https://www.mydelica.com). DE is a scientific advisor to Small Pharma and Field Trip. DJN is an advisor to COMPASS Pathways and AWAKN. All of the above are companies or organisations investing in psychedelic therapy. ACW has received research funding from the Multidisciplinary Association for Psychedelic Studies. AG and AM have no relevant conflicts of interest. JFR is Co-founder (and equity holder) of Psy Therapeutics LLC, an early discovery pipeline company focused on novel therapeutics discovery for psychiatric disorders and dementia (www.psythx.com), scientific advisor to Luminopia and scientific advisor to Terran Biosciences. DJN is editor of this journal and RCH, HK and DE are colleagues.

References

    1. Alboni S, Van Dijk RM, Poggini S, et al.. (2017) Fluoxetine effects on molecular, cellular and behavioral endophenotypes of depression are driven by the living environment. Mol Psychiatry 22: 552–561. - PMC - PubMed
    1. Andersen KAA, Carhart-Harris R, Nutt DJ, et al.. (2020) Therapeutic effects of classic serotonergic psychedelics: A systematic review of modern-era clinical studies. Acta Psychiatr Scand 143: 101–118. - PubMed
    1. Armitage R. (2021) Antidepressants, primary care, and adult mental health services in England during COVID-19. Lancet Psychiatry 8: e3. - PMC - PubMed
    1. Brainstorm C, Anttila V, Bulik-Sullivan B, et al.. (2018) Analysis of shared heritability in common disorders of the brain. Science 360. - PMC - PubMed
    1. Brandessence Market Research Company Pvt Ltd (2019) Antidepressant drugs market size, share, current trends, opportunities, competitive analysis and forecast to 2019–2025. Available at: https://brandessenceresearch.biz

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