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Digital and precision clinical trials: innovations for testing mental health medications, devices, and psychosocial treatments

Neuropsychopharmacology volume 49, pages 205–214 (2024)Cite this article

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A Correction to this article was published on 02 October 2023

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Abstract

Mental health treatment advances - including neuropsychiatric medications and devices, psychotherapies, and cognitive treatments - lag behind other fields of clinical medicine such as cardiovascular care. One reason for this gap is the traditional techniques used in mental health clinical trials, which slow the pace of progress, produce inequities in care, and undermine precision medicine goals. Newer techniques and methodologies, which we term digital and precision trials, offer solutions. These techniques consist of (1) decentralized (i.e., fully-remote) trials which improve the speed and quality of clinical trials and increase equity of access to research, (2) precision measurement which improves success rate and is essential for precision medicine, and (3) digital interventions, which offer increased reach of, and equity of access to, evidence-based treatments. These techniques and their rationales are described in detail, along with challenges and solutions for their utilization. We conclude with a vignette of a depression clinical trial using these techniques.

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Author notes

  1. These authors contributed equally: John Torous, Patricia Arean.

Authors and Affiliations

  1. Departments of Psychiatry and Anesthesiology, Washington University School of Medicine, St Louis, MO, USA

    Eric Lenze

  2. Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    John Torous

  3. Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA

    Patricia Arean

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  1. Eric Lenze
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EL, JT, and PA all participated in developing the concept for the manuscript, writing the manuscript, and critically reviewing and editing it.

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Correspondence to Eric Lenze.

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Competing interests

EL: Consultant for Prodeo, Pritikin ICR, IngenioRx, Boehringer-Ingelheim, and Merck. Research funding from Janssen. Patent application pending for sigma-1 receptor agonists for COVID-19. JT: scientific advisory board of Precision Mental Wellness. PA: scientific advisory board of Headspace Health, Koa Health, and Chorus Sleep.

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Lenze, E., Torous, J. & Arean, P. Digital and precision clinical trials: innovations for testing mental health medications, devices, and psychosocial treatments. Neuropsychopharmacol. 49, 205–214 (2024). https://doi.org/10.1038/s41386-023-01664-7

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