NEW YORK (GenomeWeb) – The US Department of Veterans Affairs has launched a large, randomized clinical trial to assess whether using Myriad Genetics' GeneSight pharmacogenetic test helps get patients with major depressive disorder to the right treatment and improves their outcomes.
The $12 million Precision Medicine in Mental Health Care study, or PRIME, is being funded by the VA and will involve 2,000 veterans with major depressive disorder and 250 healthcare providers across 21 VA medical centers. The study will randomize patients to one arm in which patients immediately get treatment based on GeneSight results, or to the comparator arm in which patients receive standard treatment for six months and then receive PGx results.
Researchers are interested in assessing whether the use of GeneSight sooner improves remission rates and reduces the use of contraindicated medications. The study will also track veterans' adherence to the recommended drug, quality of life outcomes, and provider attitudes. The study is slated for completion in 2021.
Before this study, doctors had the ability to order GeneSight for veterans through a Federal Supply Schedule contract that the VA approved three years ago. However, ordering doctors had to show the test was medically necessary.
The PRIME study will further inform the medical necessity of the test in the veteran population. "Through this study we hope to learn if there is an association between the GeneSight test and more effective treatment for veterans suffering from major depressive disorder, a condition which affects many veterans," David Oslin, the study's principal investigator and chief of behavioral health at the Corporal Michael J. Crescenz VA Medical Center, said in a statement.
In a statement announcing the launch of the study, Myriad estimated that around 20 percent of the 2.6 million veterans deployed to Iraq or Afghanistan came back with major depressive disorder or an associated mental health condition. Further, suicide rates among veterans are double the rate of the overall US population.