ValueOptions®, Inc. a health improvement company specializing in mental and emotional well-being and recovery, and Genomind, a personalized medicine company, today announced an innovative study that uses pharmacogenomic testing to treat patients diagnosed with psychotic disorders, including schizophrenia and bipolar disorder. The study will be conducted at North Shore-LIJ Health System's Zucker Hillside Hospital, a nationally recognized behavioral health center in Glen Oaks, NY.
The prospective study will compare outcomes from an assay-guided-treatment (AGT) group, using Genomind's Genecept™ Assay, with a treatment-as-usual (TAU) group. The objectives of the study include determining the efficacy of testing, the impact of testing on treatment decisions, and the impact on resource utilization. The outcomes that will be measured include the time to discontinuation of first medication, the prescribing behavior change based upon pharmacogenomics testing, the treatment efficacy, the adverse drug response, and resource utilization/cost effectiveness. Patient recruitment begins in the second quarter of 2014.
The Genecept Assay is a comprehensive simple-to-use saliva-based test for understanding genetic and biological markers that can inform clinicians' treatment decisions for patients diagnosed with a range of psychiatric conditions.
"We are excited to sponsor this study with Genomind and Zucker Hillside in order to learn more about this innovative approach for translating the use of biomarkers to clinical practice and patients, which could lead to treatments for schizophrenia and bipolar disorder that are specifically tailored for each patient, " said Dr. Hal Levine, Chief Medical Officer, ValueOptions. "Our mission in serving our customers and members, and in partnering with our network providers, is to be a leader in bringing them the best information, practices, and scientific translation."
According to the National Institute of Mental Health (NIMH), over 26 percent of Americans – 1 in 4 adults – experience mental health disorders. Psychotic disorders such as schizophrenia and bipolar are chronic illnesses affecting more than 8 million adults. Poor medication adherence is the most common cause of relapse in these patients, and large scale trials show that a substantial portion of patients discontinue their antipsychotic medications due to lack of efficacy or intolerable side effects. There is significant room to prevent relapse for these patients through the use of pharmacogenomic testing to select treatments personalized to decrease side effects and improve efficacy.
"Treating patients diagnosed with psychosis is a challenge for clinicians," said Jianping Zhang, MD, PhD, Principal Investigator of the study. "Medication is an important part of treatment, and side effects must be managed. Pharmacogenomic testing as with the Genecept Assay is a promising tool to help guide medication management based upon an individual patient's genetic and biologic information." Anil Malhotra, MD, Director of Psychiatric Research at Zucker Hillside, is co-Principal Investigator with Dr. Zhang and a member of Genomind's Scientific Advisory Board.
"Genomind is devoted to improving treatment for patients with psychiatric conditions, and we are proud to work with leaders ValueOptions and Zucker Hillside who share this mission," said Dr. Jay Lombard, Chief Scientific Officer, Medical Director, and Co-Founder of Genomind. "Even more importantly, this study at Zucker Hillside offers a treatment center known for its pioneering programs, allowing us to understand how treatment options can best be used in real world settings."