The Rapid Mood Screener (RMS) for Bipolar I Disorder: Study Design for a Confirmatory Study Evaluating Performance in Real-World Settings

This work was sponsored by AbbVie Background: IDgenetix is a pharmacogenomics (PGx) test that incorporates the results of a multi-gene variant panel with drug-drug interactions (DDI) and lifestyle factors to provide medication recommendations for patients diagnosed with major depressive disorder (MDD) or other mental illnesses. In a randomized controlled trial (RCT), IDgenetix-guided drug recommendations were shown to significantly improve remission rates compared to the standard empirical approach (Bradley et al. 2018). Methods: This study analyzed genotype/phenotype, drug recommendations, clinician adherence, and clinical outcomes for the contribution of DDI and lifestyle factors with drug-gene interactions for PGx-guided medication management. Results: DDI and lifestyle factors accounted for 32% and 11%, respectively, of all guided drug recommendations for patients with moderate to severe depression (n=261). At the 12-week timepoint, patients in the guided group had a remission rate of 41%, compared to just 27% for the unguided group (p=0.03). Among a subset of the patients taking baseline antidepressants incongruent with their IDgenetix reports (n=106), remission rates were even more significantly improved for the guided group compared to the unguided group (47% vs. 22%, p=0.01). Conclusion: IDgenetix is the only clinically validated PGx test that combines DDI and lifestyle factors with drug-gene interactions and demonstrates improved outcomes through a published RCT. The addition of DDI and lifestyle factors to drug-gene interactions significantly impacted the number of drug recommendations within this study and contributed to improved remission rates for patients with moderate to severe depression.