Assurex Health, a wholly-owned subsidiary of Myriad Genetics Inc, both in Salt Lake City, has announced results from a large, well-controlled pharmacogenomics study among patients with major depressive disorder (MDD), suggesting that patients are 50% more likely to achieve remission, and 30% more likely to respond to treatment, when their medication selection is guided by the GeneSight psychotropic genetic test.1
“We now have the results from the largest-ever pharmacogenomics clinical study in patients with moderate to very severe depression,” says Bryan Dechairo, PhD, executive vice president of clinical development at Myriad Genetics. “The important news here is that when doctors used the GeneSight genetic test to guide their selection of antidepressants, patients experienced significantly higher rates of response and remission as well as better overall symptom relief.”
The 24-week study included 1,167 patients with moderate to very severe depression who had failed treatment with at least one antidepressant medication. Patients were divided into two treatment arms: the GeneSight psychotropic test arm (n = 560), in which clinicians used GeneSight test results to guide treatment decisions; and a treatment-as-usual arm (n = 607), in which psychiatrists and primary care physicians prescribed medication as they normally would, without the benefit of genetic testing.
The Hamilton Depression scale (HAM-D17) was used to measure the key endpoints of remission (achieving a HAM-D17 score <7), response (50% decrease in HAM-D17 from baseline), and symptom improvement (percent change in HAM-D17 from baseline) at week 8. The durability of patients’ mental health outcomes was assessed at week 24.
“This is the first-ever prospective, large-scale, double-blind, randomized controlled trial evaluating combinatorial pharmacogenomics testing in patients with treatment-resistant major depressive disorder,” says John Greden, MD, principal investigator, executive director of the University of Michigan’s comprehensive depression center, and an unpaid consultant to Assurex Health. “GeneSight-guided care was compared to physicians’ optimized treatment plans. The results indicate that patients fared significantly better with the pharmacogenomics approach than with usual care, despite this being a difficult-to-treat patient population. The improvements continued to increase as the study was extended to 24 weeks.”
At week 8, individuals in the GeneSight cohort were 50% more likely to achieve remission, and 30% more likely to achieve treatment response, as compared to those in the treatment-as-usual group. The GeneSight-guided cohort also demonstrated higher symptom improvement that approached statistical significance (Figure 1).
Importantly, remission and response rates for patients in the GeneSight test arm continued to improve through week 24 (Figure 2), as did symptom improvement (Figure 3), demonstrating the long-term durability of the results.
“Achieving response and remission are the ultimate goals of treating patients with depression,” Greden says. “These results demonstrate promise for a pharmacogenomics approach to help improve short- and long-term response and remission rates in depressed adults compared to clinicians’ usual approaches to medication selection.”
For more information, visit Myriad Genetics.
- Greden JF. Combinatorial pharmacogenomics significantly improves response and remission for major depressive disorder: a double-blind, randomized control trial [abstract]. Poster P5-110, presented at the annual meeting of the American Psychiatric Association, New York City, May 5–9, 2018. In Poster Proceedings: American Psychiatric Association Annual Meeting [online]. Available at: www.psychiatry.org/psychiatrists/meetings/annual-meeting/guide [other program documents]. Accessed June 14, 2018.