Health AI Central
Peer-Reviewed Publication
NPP Digit Psychiatry Neurosci2026;4(1)September 18, 2026Journal Article

Toward actionable biomarkers in psychiatry: a collaborative roadmap for precision clinical trials. An ACNP position paper.

Sahib S Khalsa1, Deanna Barch2,3, Linda S Brady4, Teresa Buracchio5, William A Carlezon6, Christopher Chatham7, Wayne C Drevets8, C Neill Epperson9, Amit Etkin10,11, Bernard Fischer5, Danielle L Graham12, Steven C Hoffmann13, Bashkim Kadriu14, Martien J H Kas15, Hartmuth Kolb8, Marion Leboyer16,17,18, Sarah H Lisanby19, Lauren Liss20, Husseini K Manji21,22,23, Valentina Mantua5, Hugh M Marston20, William Potter24, Frank Yocca25, Kerry J Ressler26
1Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
2Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.
3Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.
4National Institute of Mental Health, Bethesda, MD, USA.
5Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, United States. Food and Drug Administration, Silver Spring, MD, USA.
6McLean Hospital, Mass General Brigham Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA.
7Shionogi, Inc, Florham Park, NJ, USA.
8Johnson & Johnson, San Diego, CA, USA.
9Department of Psychiatry, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.
10Alto Neuroscience, Inc., Mountain View, CA, USA.
11Stanford Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
12Department of Biomarkers and Systems Biology, Biogen, Cambridge, MA, USA.
13Foundation for the National Institutes of Health, North Bethesda, MD, USA.
14Bristol Myers Squibb, Lawrence, NJ, USA.
15Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, the Netherlands.
16Fondation FondaMental, Créteil, France.
17Translational Neuropsychiatry Laboratory, Inserm U955, Paris-Est Créteil University, Créteil, France.
18Department of Psychiatry, Mondor University Hospital, AP-HP, Créteil, France.
19Arizona State University John Shufeldt School of Medicine and Medical Engineering, Phoenix, AZ, USA.
20Neuroscience and Mental Health Discovery Research, Boehringer Ingelheim, Biberach, Germany.
21Oxford University, Oxford, United Kingdom.
22Yale University, New Haven, CT, USA.
23UK Government Mental Health Mission, London, United Kingdom.
24Independent Expert, Philadelphia, PA, USA.
25BioXcel Therapeutics Inc, New Haven, CT, USA.
26McLean Hospital, Mass General Brigham Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA. kressler@mclean.harvard.edu.
PubMed DOI

Abstract

Psychiatric drug development remains constrained by diagnostic heterogeneity, insufficient and inconsistent drug response, high placebo response rates, and the absence of validated biomarkers that can reliably guide patient stratification, trial design, and regulatory decision-making. Despite substantial advances in neuroscience, few biomarkers in psychiatry have progressed beyond exploratory use,…

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