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CNS Drug Development

Lessons Learned Part 2. Symptoms, Not Syndromes as Targets Consistent with the NIMH Research Domain Approach

PRESKORN, SHELDON H., MD

Journal of Psychiatric Practice®: January 2015 - Volume 21 - Issue 1 - p 60–66
doi: 10.1097/01.pra.0000460622.33300.64
COLUMNS: Psychopharmacology
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This column is the second in a series exploring lessons for psychiatric drug development that can be learned from the development of 6 central nervous system drugs with novel mechanisms of action over the past 25 years. Part 1 presented a brief overview of the neuroscience that supported the development of each of these drugs, including the rationale for selecting their targets and indications. This column reviews specific principles involved in the development of these 6 drugs that have important implications for the future of psychiatric drug development. These include focusing on efficacy for a specific symptom or behavior rather than a broad syndrome, choosing a target in the brain with a specific behavioral output that is conserved from lower mammalian to human brains, and measuring outcomes based on behavioral phenomena that can be readily measured in an unambiguous parametric way. It is hoped that the Research Domain Criteria initiative of the National Institute of Health will promote research advances consistent with this model. (Journal of Psychiatric Practice 2015;21:60–66)

PRESKORN: University of Kansas School of Medicine-Wichita and Kansas University-Wichita Clinical Trials Unit.

Over his career, Dr. Preskorn has worked with over 125 pharmaceutical companies in the United States and throughout the world. Over the past year, Dr. Preskorn has received grants/research support from or has served as a consultant, on the advisory board, or on the speakers bureau for Assurex Health, Cubist/Trius, Eisai, Envivo, Johnson & Johnson, Merck, Naurex, Pfizer, Stanley Medical Research Institute, Sunovion, and Taisho.

Please send correspondence to: Sheldon H. Preskorn, MD, Kansas University-Wichita Clinical Trials Unit,1010 N. Kansas, Wichita KS 67214, spreskorn@kumc.edu

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