February 16, 2012 – Boston, MA – Genomind today announced that the Massachusetts General Hospital (MGH) Department of Psychiatry is beginning a major inpatient study examining the use of genetic biomarker data to inform clinician treatment decisions for patients with treatment resistant major depressive disorder.
The IRB-approved study compares treatment-as-usual vs. assay-guided treatment in inpatient adults with treatment resistant depression (TRD). Assay-guided treatment in the study will use the Genecept™ Assay. Recruitment begins immediately. The primary study objective is improvement in depressive symptoms from baseline to 6 months, and secondary endpoints including change in clinician behavior, as well as decrease in costs.
“Until recently, clinicians have not had tools available for enhancing decision-making to increase the chance for treatment response and decrease the risk for adverse drug reaction, which can reach 5-10%,” said John D. Matthews, MD, Director of Inpatient Research and Training at MGH and an Assistant Professor at Harvard Medical School. “Our understanding of the genetic basis of inter-individual variation of drug response, which can vary between 30-60%, has been advanced by genome sequencing, the development of pharmacogenetic biomarkers to predict treatment response and risk for toxicity, and pharmacogenetic genotyping of metabolic capacity.”
“We have worked closely with the MGH Psychiatry Department leadership for years, in recognition of their position as leaders who share our vision of bringing the best of science to patients suffering from treatment resistant disorders,” said Jay Lombard, DO, Chief Scientific Officer and Medical Director, Genomind. “Studies and data collection are essential to helping transform scientific discovery into clinical practice with the patient in mind.”
The focus of this study will be on pharmacogenetic genotyping of metabolic activity for decision-making in the treatment of major depressive disorder with antidepressants. Future genome-wide association study analyses will also be undertaken to identify biomarkers that might be used to predict treatment response and tolerability. For further information about other studies involving the Genecept Assay, go to ClinicalTrials.gov.
The Genecept Assay combines a proprietary panel of genetic tests and an analytical report to be used by clinicians. In addition, the Genecept Assay is coupled with Genomind psychopharmacologist assistance for clinicians, together with emerging education and information concerning neuropsychiatric disorders and pharmacogenomics. Genomind has unique intellectual property for this integrated approach and product.
Genomind is a company specializing in neuropsychiatric personalized medicine and was formed to facilitate the adoption of personalized medicine into psychiatry by providing genetic information for clinicians to better understand the patient. Genomind was founded by Ronald I. Dozoretz, MD, a psychiatrist who has devoted his career to improving mental health and bringing innovations in science, delivery, and access to mental health patients. Jay Lombard, DO, a neurologist, is Co-founder of Genomind and is a critically acclaimed author and nationally recognized thought leader in neuropsychiatry practice and research. Learn more at http://www.genomind.com.
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