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PRIME Care Study Shows Patients Whose Clinicians Had Access to the GeneSight® Test Are More Likely to Achieve Remission from Depression

Genetic Insights

Major depressive disorder (MDD), also known as clinical depression, is a serious and all-too common medical illness, affecting an estimated 21 million U.S. adults, according to the National Institutes for Mental Health.

Clinical depression among veterans is an especially pressing concern, with the U.S. Department of Veterans Affairs (VA) declaring suicide prevention among all veterans its “top clinical priority.” According to the U.S. Government Accountability Office (GAO) website, the number of veterans receiving mental health care from the VA increased 90% from fiscal years 2006 to 2019. The website reports that veterans are 1.5 times more likely to die by suicide than people in the general population.

U.S. Department of Veterans Affairs Study

With its heightened interest in addressing veterans’ mental health, the VA undertook a study looking at pharmacogenomic (PGx) testing in mental health care. PGx tests, like the GeneSight® Psychotropic test, examine how genes may affect the body’s metabolism or response to certain medications.

The researchers wanted to know whether access to the genetic test results impacted treatment decisions, and improved patient outcomes for those with MDD.

The study, conducted independently by the VA and published in the Journal of the American Medical Association (JAMA) in July 2022, found that veterans’ rates of remission from MDD were significantly improved when healthcare providers had access to the GeneSight test.

The PRIME Study Findings

The study met its objectives by achieving statistically significant results on two co-primary endpoints (endpoints are the main results that are measured at the end of the study).

One endpoint showed that over 24 weeks, the PGx-guided group had a 28% greater likelihood of achieving remission from MDD symptoms.

The other endpoint showed that patients in the PGx-guided group were less likely to be prescribed medications with predicted gene-drug interactions, compared to the “treatment as usual” group, within the first 30 days after being assigned to a group.

“The study found a marked shift in prescribing away from medications with significant drug-gene interactions or moderate drug-gene interactions,” according to a VA story about the study. “Overall, 59% of the patients in the genetic testing group received a medication with no predicted drug-gene interaction, compared with 26% in the control group. The researchers defined that difference as ‘statistically significant and clinically meaningful.’”

On the whole, the patients who underwent GeneSight testing had more positive outcomes in depression remission, depression response, and symptom improvement compared with patients receiving treatment as usual.

How Do the Results of the PRIME Study Help Me?

Genes play an important role in how our bodies metabolize certain medications, such as antidepressants. Our unique genetic profile contains six enzymes that metabolize 90 percent of all medications. These genes and enzymes help determine our individual rate of metabolism, which varies from person to person.

Depending on your genetic profile, you may process some medications too quickly, or others, too slowly, which may impact treatment outcomes. The GeneSight test analyzes how your genes may affect your outcomes with medications commonly prescribed to treat depression, anxiety, ADHD, and other mental health conditions. It provides your clinician with information about which medications may require dose adjustments, may be less likely to work for you or may have an increased risk of side effects based on your genetic makeup.

For more information about the GeneSight test, visit https://genesight.com/product/.

About the Precision Medicine in Mental Health Care (PRIME) Study

  • The PRIME Care study is the largest pharmacogenomic (PGx) randomized controlled trial (RCT) ever conducted in mental health.  Learn more about RCTs here: https://genesight.com/genetic-insights/randomized-controlled-trials-the-gold-standard/
  • Involved 1,944 veterans and 22 VA centers nationwide
  • Patients were assigned randomly to one of two groups: the group whose care was informed by PGx testing, and another group who received treatment as usual
  • Led by David Oslin, M.D., director of VA’s VISN 4 Mental Illness, Research, Education, and Clinical Center (MIRECC)

 

The results of the GeneSight test are intended to supplement other clinical factors considered by a healthcare provider during a comprehensive medical assessment to help inform treatment decisions. Not all patients who receive the GeneSight test will have improved outcomes. The GeneSight test is intended to supplement a clinicians comprehensive medical assessment.

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