Innovations In Clinical Neuroscience

ISCTM Supplement 2015

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 2 , N U M B E R 3 ā€“ 4 , S U P P L E M E N T A , M A R C H ā€“ A P R I L 2 0 1 5 ] 26S ABSTRACT The success rate in the development of psychopharmacological compounds is insufficient. Two main reasons for failure have been frequently identified: 1) treating the wrong patients and 2) using the wrong dose. This is potentially based on the known heterogeneity among patients, both on a syndromal and a biological level. A focus on personalized medicine through better characterization with biomarkers has been successful in other therapeutic areas. Nevertheless, obstacles toward this goal that exist are 1) the perception of a lack of validation, 2) the perception of an expensive and complicated enterprise, and 3) the perception of regulatory hurdles. The authors tackle these concerns and focus on the utilization of biomarkers as predictive markers for treatment outcome. The authors primarily cover examples from the areas of major depression and schizophrenia. Methodologies covered include salivary and plasma collection of neuroendocrine, metabolic, and inflammatory markers, which identified subgroups of patients in the Netherlands Study of Depression and Anxiety. A battery of vegetative markers, including sleep- electroencephalography parameters, heart rate variability, and bedside functional tests, can be utilized to characterize the activity of a functional system that is related to treatment refractoriness in depression (e.g., the renin-angiotensin-aldosterone system). Actigraphy and skin conductance can be utilized to classify patients with schizophrenia and provide objective readouts for vegetative activation as a functional marker of target engagement. Genetic markers, related to folate metabolism, or folate itself, has prognostic value for the treatment response in patients with schizophrenia. Already, several biomarkers are routinely collected in standard clinical trials (e.g., blood pressure and plasma electrolytes), and appear to be differentiating factors for treatment outcome. Given the availability of a wide variety of markers, the further development and integration of such markers into clinical research is both required and feasible in order to meet the benefit of personalized medicine. Taking Personalized Medicine Seriously: Biomarker Approaches in Phase IIb/III Studies in Major Depression and Schizophrenia by HARALD MURCK, MD, PhD; THOMAS LAUGHREN, MD; FEMKE LAMERS, PhD; ROSALIND PICARD, ScD; SEBASTIAN WALTHER, MD; DONALD GOFF, MD; AND STEPHEN SAINATI, MD, PhD Dr. Murck is with Acorda Therapeutics in Ardsley, New York, and Phillips-University Marburg, Marburg, Germany (Dr. Murck was with Covance Inc., Princeton, New Jersey, during the preparation of this manuscript); Dr. Laughren is with Laughren Consulting, Rockville, Maryland, USA; Dr. Lamers is with the Department of Psychiatry, VU University Medical Center / GGZ inGeest, Amsterdam, The Netherlands; Dr. Picard is with MIT Media Laboratory and Empatica, Inc., Boston, Massachusetts, USA; Dr. Walther is with University Hospital of Psychiatry, Bern, Switzerland; Dr. Goff is with the Department of Psychiatry, NYU Langone Medical Center, New York, New York, USA; Dr. Sainati is with FORUM Pharmaceuticals, Boston, Massachusetts, USA. Innov Clin Neurosci 2015;12(3ā€“4 Suppl A):26Sā€“40S FUNDING: No funding was provided for this article. FINANCIAL DISCLOSURES: Dr. Murck has no conflicts of interest relevant to the content of this article. Dr. Laughren is a part-time employee of the MGH CTNI and consults or has consulted for AbbVie, Acadia, Alcobra, AstraZeneca, Axsome, Camurus, Cerecor, Corcept, Curemark, Dart NeuroScience, Delpor, Durect, Edgemont, EnVivo, ERT, Fabre Kramer, Gedeon Richter, Janssen, JDS Therapeutics, King & Spalding, Lilly, MAPS, MedAvante, Medgenics, Naurex, Neurenl, Neurocrine Biosciences, NIMH, Noven, Omeros, Pfizer, Quinn Emanuel, Retrophin, Reviva, Roche, Salamandra, Shire, Spinifex, Sunovion, Taisho, Targacept, Teva, Theravance, Tonix, Transition Therapeutics, Ulmer & Berne, and Zogenix. Dr. Lamers is supported by a FP7-Marie Curie CIG (334065). Dr. Picard is Chairman of the Board, Chief Scientist, and shareholder with Empatica, Inc., a small company that makes a sensor that can provide the data described in part of this research (this article does not promote any Empatica products). Dr. Walther has no conflicts of interest relevant to the content of this article. Dr. Goff has no conflicts of interest relevant to the content of this article. Dr. Sainati is a full-time employee of FORUM Pharmaceuticals, Inc. ADDRESS CORRESPONDENCE TO: Harald Murck, Acorda Therapeutics, 440 Saw Mill River Road, Ardsley, NY; E-mail: hmurck@acorda.com KEY WORDS: Wearable devices, biomarker, predictive marker, surrogate marker, treatment outcome P R O C E E D I N G S

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