Use of experimental medicine approaches for the development of novel psychiatric treatments based on orexin receptor modulation

Amy C. Beckenstrom, Preciosa M. Coloma, Gerard R. Dawson, Ailidh K. Finlayson, Asad Malik, Anke Post, Michel Alexander Steiner, Marc N. Potenza

Research output: Contribution to journalReview articlepeer-review


Despite progress in understanding the pathological mechanisms underlying psychiatric disorders, translation from animal models into clinical use remains a significant bottleneck. Preclinical studies have implicated the orexin neuropeptide system as a potential target for psychiatric disorders through its role in regulating emotional, cognitive, and behavioral processes. Clinical studies are investigating orexin modulation in addiction and mood disorders. Here we review performance-outcome measures (POMs) arising from experimental medicine research methods which may show promise as markers of efficacy of orexin receptor modulators in humans. POMs provide objective measures of brain function, complementing patient-reported or clinician-observed symptom evaluation, and aid the translation from preclinical to clinical research. Significant challenges include the development, validation, and operationalization of these measures. We suggest that collaborative networks comprising clinical practitioners, academics, individuals working in the pharmaceutical industry, drug regulators, patients, patient advocacy groups, and other relevant stakeholders may provide infrastructure to facilitate validation of experimental medicine approaches in translational research and in the implementation of these approaches in real-world clinical practice.

Original languageEnglish
Article number105107
JournalNeuroscience and Biobehavioral Reviews
Early online date23 Feb 2023
Publication statusPublished - 30 Apr 2023


  • Clinical trial
  • Cognitive task
  • Drug development
  • Experimental medicine
  • Orexin agonist
  • Orexin antagonist
  • Orexin system
  • Performance-outcome assessment
  • Psychiatry

ASJC Scopus subject areas

  • Neuropsychology and Physiological Psychology
  • Cognitive Neuroscience
  • Behavioral Neuroscience


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