Study Design: This was a double-blind, randomized controlled trial of 49 subjects with a primary diagnosis of major depressive disorder.* It compared 10 weeks of treatment guided by GeneSight® with unguided treatment as usual (TAU).
*Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).
Higher response and remission rates: When physicians’ decisions regarding medication change were guided by GeneSight, the likelihood of response and remission was more than double the TAU group.
GeneSight can predict patients’ response to medications: GeneSight accurately predicted those patients who were more likely to have poor depression outcomes due to gene-drug interactions. TAU subjects who had been prescribed medications that were genetically sub-optimal had almost no improvement in depressive symptoms over the 10 weeks of the trial.
Genetically optimal medications significantly improve patient outcomes: When subjects who had been on genetically sub-optimal medications were switched to a genetically optimal medication(s) based on their GeneSight® report, the subjects experienced a 33.1% improvement in symptoms (HAM-D17) at ten weeks compared to red category TAU subjects who had 0.8% improvement.
Patients benefit when clinicians have access to meaningful pharmacogenomic information: Depression outcomes improved for patients when clinicians were provided and acted on pharmacogenomic information to make genetically appropriate treatment adjustments.