Schizophrenia Drug Development May Be Aided by Use of Image-Based Biomarkers for Glutamate-Targeted Drug Development

Researchers at Columbia University Medical Center (CUMC) and the New York State Psychiatric Institute (NYSPI) have identified biomarkers that can aid in the development of better treatments for schizophrenia. The findings were published online on November 22, 2017 in JAMA Psychiatry. The open-access article is titled "Utility of Image-Based Biomarkers for Glutamate-Targeted Drug Development in Psychotic Disorders: A Randomized Clinical Trial." In the past two decades, the pharmaceutical industry has spent over $2.5 billion to develop new schizophrenia drugs. But while many appear to be effective in animal models, most fail when tested in late-stage human clinical trials. "While a great deal of money has been invested in developing schizophrenia drugs, a similar investment hasn't been made to develop biomarkers that could improve the reliability and consistency of test results," said Daniel Javitt, MD, PhD, Professor of Psychiatry and Director of the Division of Experimental Therapeutics at CUMC, Director of Schizophrenia Research at the Nathan Kline Institute for Psychiatric Research, and Co-Principal Investigator of the study. The National Institute of Mental Health's FAST Initiative, which was established to validate the use of biomarkers to facilitate drug development, aligns with the 21st Century Cures Act passed last year by Congress. The legislation authorized the U.S. Food and Drug Administration to approve treatments based on biomarker data alone, and created a formal Biomarker Qualification Program. In this context, FAST-Psychosis researchers identified biomarkers using MRI applications to support the development of drugs that target the glutamate system. Previous studies have shown that drugs such as phencyclidine (PCP or "angel dust") and ketamine, which block glutamate receptors, cause schizophrenia-like symptoms in healthy volunteers.