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How Biomarkers Will Change Psychiatry

From Clinical Trials to Practice. Part I



Journal of Psychiatric Practice®: March 2012 - Volume 18 - Issue 2 - p 118–121
doi: 10.1097/01.pra.0000413277.11091.25
COLUMNS: Psychopharmacology

Part I of this series defines biomarkers and discusses their research utility and potential application in clinical practice. To provide a frame of reference, biomarkers commonly used in general medicine are reviewed, with a focus on low density lipoprotein as a biomarker for risk of developing atherosclerosis. The use of biomarkers in research on psychiatric illnesses is then reviewed. While biomarkers currently have only a limited role in psychiatric care, their use has improved our ability to assess potential efficacy and safety of investigational new drugs. For example, positron emission tomography can be used to measure dopamine D2 receptor occupancy (relevant for antipsychotic effects) or serotonin transporter occupancy (relevant for antidepressant effects), to establish whether an agent reaches and to what extent it affects a specific target in the brain. In the future, biomarkers are likely to become an integral component of psychiatric treatment, providing information concerning a patient’s odds of developing an illness, diagnosis, severity of illness, and level of response to therapeutic interventions. The second part of this series will discuss research on derivatives of the inflammatory biomarker thromboxane and depression. (Journal of Psychiatric Practice 2012;18:118–121)

MACALUSO and PRESKORN: Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, and KU-Wichita Clinical Trials Unit. Dr. Preskorn maintains a website at where readers can access previous columns and other publications.

Disclosure statement: Dr. Macaluso has conducted clinical trial research as principal investigator funded by Abbott, Envivo, Evotec, Lilly, Naurex, Pfizer/Wyeth, Takeda, and Targacept. Dr. Preskorn has more than 35 years of drug development research experience at all levels (preclinical through Phase IV). Over his career, he has worked with over 85 companies and has been a principal investigator on over 300 clinical trials, including trials of every antidepressant marketed in the United States over the last 25 years. Over the past 12 months, in his administrative capacities and as principal investigator, Dr. Preskorn has received grants/research support from or has served as a consultant for, on the advisory board of, or on the speakers bureau for the following entities: Abbott, Biovail, Boehringer-Ingelheim, Bristol-Myers Squibb, Cyberonics, Dey Pharma, Eisai, Eli Lilly, EnViVo, Ipsen, Johnson & Johnson, Lundbeck, Merck, Naurex, NIMH, Orexigen, Otsuka, Pierre Fabre, Pfizer, Stanley Med. Res. Institute, Sunovion, and the U.S. Food and Drug Administration.

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