To study benefits of genetic testing to guide mental health medication decisions
Assurex Health and Canada's Centre for Addiction and Mental Health (CAMH) today announced they have received a $6 million grant from Genome Canada, an agency of the Canadian government, to study the benefits of genetic testing to guide medication decisions for patients with depression or schizophrenia.
The clinical trial is the first to evaluate Canadian patients, including patients with schizophrenia, using personalized decision guidance provided by the GeneSight® Psychotropic test, developed by Assurex Health in Mason, Ohio. The grant funds a joint Genomic Applications Partnership Program (GAPP) to be managed by CAMH and Assurex Health, with administrative and programmatic support from the Ontario Genomic Institute.
GeneSight technology is based on combinatorial pharmacogenomics (CPGxTM), the study of how variations in multiple genes influence an individual's response to medications, as well as evidence-based medicine and clinical pharmacology. The technology analyzes response to medicines commonly prescribed to treat depression and schizophrenia, as well as anxiety, posttraumatic stress disorder (PTSD), bipolar disorder, and other behavioral health conditions.
Three Year Study to Examine Clinical Outcomes, Cost Benefits
"Genome Canada is pleased to support this partnership that will accelerate the translation of tailored treatments for mental health conditions, avoiding adverse drug reactions. This in turn will reduce burden and cost to Canada's health care system," said Dr. Pierre Meulien, President and CEO of Genome Canada.
The study, "Clinical Utility and Enhancements of a Pharmacogenomic Decision Support Tool for Mental Health Patients," will be funded over three years. Assurex Health and CAMH investigators, working with clinicians from the greater Toronto area, will conduct a 12 week randomized and blinded study with Canadian patients diagnosed with depression or schizophrenia. Healthcare providers of patients in both disease categories for whom prior prescription drug treatment has failed will receive personalized guidance for medication selection and dosing using the GeneSight Psychotropic test.
"The study will also evaluate the ability of genetic variants discovered at CAMH to predict important side effects of psychiatric medications, and will collect economic data on how testing impacts health care costs," said C. Anthony Altar, PhD, Senior Vice President, Neurosciences of Assurex Health and co-principal investigator on the grant. "We will look at how prescribing more appropriate medications specifically suited to individual patient's genetics correlates to clinical outcomes and cost benefits."
Clinical improvements will be compared among three groups: patients whose healthcare providers receive the GeneSight Psychotropic report, patients whose healthcare providers receive a variation of the GeneSight report enhanced with genetic variants discovered at CAMH, and patients who are treated as usual, without the benefit of guidance by either of the GeneSight tests.
"The new study, generously supported by the GAPP award, will provide a clear picture of how pharmacogenomic medication guidance may help Canadian patients, and will enhance the science behind tests like GeneSight," said Dr. James L. Kennedy, Director of Molecular Science in CAMH's Campbell Family Mental Health Research Institute and co-principal investigator on the grant.
Multiple clinical studies published in peer-reviewed journals in the U.S. have demonstrated the clinical validity, utility, and economic benefits of the GeneSight test in making decisions about treating patients with major depression, compared with treatment as usual. , This strong data is driving growing reimbursement coverage.
Study Conducted at 10 Sites with 1,200 Patients
This is the first clinical study of this type conducted in Canada. The trial will be conducted at 10 sites throughout Ontario, primarily in Toronto, and will include 1,200 patients.
In any given year, one in five Canadians experiences a mental health or addiction problem. Mental illness is the second leading cause of disability and premature death in Canada. The economic burden of mental illness in Canada is estimated at $51 billion per year. This includes health care costs, lost productivity, and reductions in health-related quality of life.