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FAST-PS: A New Initiative for Developing Novel Treatments for Psychosis and Other Mental Disorders

The National Institute of Mental Health will fund research at Columbia University Department of Psychiatry and New York State Psychiatric Institute (NYSPI) to speed the development of effective psychotropic agents and improve treatment for those suffering from mental illnesses

There is a serious crisis in drug development for mental disorders. The numbers of potential new compounds in the research pipeline has dropped precipitously in the past decade.  The expense of development and lack of progress has led a number of pharmaceutical companies to curtail or cease drug development for brain disorders.  This lack of development and innovation seriously impacts the future of treatment for those suffering the burden of psychosis and other mental disorders.

Recently, the National Institutes of Mental Health (NIHM) awarded researchers at the Research Foundation for Mental Hygiene (RFMH) at the Columbia University Department of Psychiatry and New York State Psychiatric Institute (NYSPI) a major contract to implement the NIMH FAST-PS Initiative. The FAST-PS Initiative is designed to rapidly and efficiently identify and test the most promising new compounds as treatments for psychotic disorders. This new paradigm in experimental medicine studies, termed ‘fast-fail’, entails conducting ‘proof of concept’ trials using biomarkers to provide early evidence of mechanism of action and clinical efficacy.  The contract, if fully executed, will provide up to $9M in funding over the next 3 years.

The research team, known as the Academic Consortium for Early Stage Drug Discovery in Psychosis (ACES-DDP), will be led by Jeffrey A. Lieberman, MD, Chairman of Columbia University Department of Psychiatry and Director of NYSPI. Daniel C. Javitt, M.D., Ph.D. will serve as co-PI and Director, for the Columbia performance site; Ragy Girgis, M.D. and Joshua T. Kantrowitz, M.D. will serve as co-investigators.  Early stage clinical trials will be performed in collaboration with Serge Cremers, Pharm.D., Ph.D. and the staff and facilities of the Irving Institute for Clinical and Translational Research at Columbia University Medical Center.

In addition to the Columbia/NYSPI site, the ACES-DDP consortium will involve experts in schizophrenia research and five collaborating institutions including Robert Buchanan, MD, Maryland Psychiatric Research Center (MPRC); Cameron Carter, MD, University of California – Davis; Donald Goff, MD, New York University Langone Medical Center/Nathan Kline Institute (NKI); John Krystal, MD, Yale University; and Stephen Marder, MD, University of California – Los Angeles which will serve as performance sites.  State of the art brain imaging and electrophysiological technology will be used to assess the effects of compounds selected for investigation in healthy volunteers and those suffering from serious mental disorders.

“FAST-PS is a badly needed initiative by the NIMH to spur innovative drug development at a time when the pharmaceutical industry has retreated from the challenge of meeting overwhelming unmet clinical needs,” said Jeffrey Lieberman, MD, who will lead this project.

“My congratulations to Dr. Lieberman for winning this crucially important treatment development contract. The promise of scientific progress to lessen the pain and costly disability associated with mental illness has not yet been met. I commend NIMH for recognizing this and creating this mechanism to slow the time lag between development of new scientific knowledge and the availability of safe and effective treatments. The fact that two New York State Office of Mental Health Research Institutes will participate shows the significance of the work being performed at these centers. This contract awarded by NIMH, to fast-track the most effective psychotropic agents through the development process, will not only deliver much needed psychiatric medicine to those who need it most but will also ensure that New York State remains a leader in the field of mental health innovation.” said Commissioner Michael Hogan, New York State Office of Mental Health.

Columbia Psychiatry is ranked among the best departments and psychiatric research facilities in the nation and has contributed greatly to the understanding and treatment of psychiatric disorders. Located at the New York State Psychiatric Institute on the NewYork-Presbyterian Hospital/Columbia University Medical Center campus in northern Manhattan, the department enjoys a rich and productive collaborative relationship with physicians in various disciplines at Columbia University’s College of Physician’s and Surgeons. Columbia Psychiatry is home to distinguished clinicians and researchers noted for their clinical and research advances in the diagnosis and treatment of depression, suicide, schizophrenia, bipolar and anxiety disorders, eating disorders, and childhood psychiatric disorders.  Columbia Psychiatry’s extraordinary scientific base is supported by more federal grants than any other psychiatry department in the nation.

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