Study Design: This was a 24 week, double-blind, multi-center, randomized controlled trial of 1,167 subjects with major depressive disorder from 20 academic sites and 40 community sites.* The study assessed the impact of the GeneSight® Psychotropic test on psychiatric treatment response compared to unguided treatment as usual (TAU).
*Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).
Significant improvement in remission and response: Patients receiving the GeneSight Psychotropic test experienced a 50% improvement in remission rates and a 30% increase in response rates at week 8 compared to TAU. Additionally, symptom improvement in the GeneSight-guided group trended toward significance at week 8 compared to TAU.
The GeneSight effect on response and remission was durable over 6 months: Remission and response rates continued to increase throughout the 24 week study period.
Switching to a genetically optimal medication improves patient outcomes: Symptom improvement, response, and remission were significantly improved when patients on a genetically suboptimal medication were switched to a genetically optimal medication by week 8 compared to those who remained on genetically suboptimal medications.