Clinical validation of combinatorial pharmacogenomic testing and single-gene guidelines in predicting psychotropic medication blood levels and clinical outcomes in patients with depression

We evaluated the clinical validity of a combinatorial pharmacogenomic test and single-gene Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines against patient outcomes medication blood levels to assess their ability inform prescribing in major depressive disorder (MDD). This is secondary analysis Genomics Used Improve DEpression Decisions (GUIDED) randomized-controlled trial, which included patients with diagnosis MDD, ≥1 prior failure. The predict increased/decreased metabolism was validated at screening (adjusted for age, sex, smoking status). predicted gene-drug interactions (pharmacogenomic test) or therapeutic recommendations (single-gene guidelines) week 8 (17-item Hamilton Depression Rating Scale; symptom improvement, response, remission). Analyses were performed taking any eligible (outcomes N=1,022, N=1,034) subset medications N=584, N=372). only significant predictor outcomes. Both predictors all when separately; however, remained both multivariate model. There no substantial differences guidelines. Overall, this evaluation demonstrates that superior compared based on individual genes.