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Clinical Studies

Clinical Information for GeneSight® Psychotropic

Summary of Clinical Studies

The clinical validity, clinical utility and economic utility of the GeneSight Psychotropic test have been evaluated in multiple peer-reviewed publications. In fact, it’s the only neuropsychiatric pharmacogenomic test backed by such extensive research. It is important to note that not all patients who received a GeneSight Psychotropic test experienced improved outcomes. However, overall, GeneSight Psychotropic helped improve outcomes compared to treatment as usual in the following studies.

Study Design: This was an 8 week, blinded, multi-center, randomized controlled trial of 1,167 subjects with major depressive disorder from 20 academic sites and 40 community sites.  The trial was unblinded after the 8 week check-in, and the subjects were followed out to 24 weeks.  The study assessed the impact of the GeneSight Psychotropic test on psychiatric treatment response compared to treatment as usual (TAU).  The raters used the Hamilton Rating Scale for Depression (HAM-D17), and the subjects had to have a minimum score of 14 in order to be eligible for the study.

Study Endpoints: GUIDED compared two active treatment arms. The primary endpoint was symptom improvement with secondary endpoints of response and remission. Symptom improvement is defined as the change in HAM-D17 score, and this is based on the group average. Response is defined as a ≥50% reduction in HAM-D17 score, and remission is defined as a HAM-D17 score ≤7.

Study Limitations: The treating clinician was not blinded to study arm, the majority of the cohort was Caucasian, the primary results may not be generalizable for patients with mild depression, and the impact of polypharmacy on patient outcomes was not evaluated.

Key Findings

Directional improvement in symptoms: On the primary endpoint of symptom improvement, the data trended toward but did not achieve statistical significance between GeneSight and TAU arms at week 8.

Significant improvement in response and remission: There were statistically significant and clinically meaningful increases in response and remission rates in the GeneSight arm versus the TAU arm at week 8.

The GeneSight effect on all endpoints was durable over 6 months: Symptom improvement, response, and remission continued to improve after unblinding at week 8 and up to 6 months.

Switching to a medication with no or moderate gene drug interaction improved patient outcomes: Symptom improvement, response, and remission were significantly improved when patients on a medication with significant gene-drug interactions were switched to a medication with no or moderate gene-drug interactions by week 8 compared to those who remained on medications with significant gene-drug interactions.