6/29/23, 1:44 AM PRIME Care Pathway Feedback Search Clinical Topics Home Studies PRIME Care PRIME Care Disease Major depressive disorder Trial question What is the effect of pharmacogenomic testing for drug-gene interactions in patients with major depressive disorder? Study design Multi-center Open label RCT Population Characteristics of study participants 25.0% female N = 1944 75.0% male 1944 patients (491 female, 1453 male) Inclusion criteria: adults with major depressive disorder who were initiating or switching treatment with a single antidepressant Key exclusion criteria: active substance use disorder; mania; psychosis; concurrent treatment with a specified list of medications Interventions N=966 pharmacogenomic-guided testing (results from a commercial pharmacogenomic test were given to clinicians) N=978 usual care (usual care and access to pharmacogenomic results after 24 weeks) https://web.pathway.md/studies/recbmilW8Hfto6rHS 1/2 6/29/23, 1:44 AM PRIME Care Pathway Primary outcome Estimated chance of no drug-gene interaction 59.3 % 59.3 44.5 % 29.6 % 25.7 Significant increase 14.8 % NNH = 3 0.0 % Pharmacogenomic-guided testing Usual care Significant increase in estimated chance of no drug-gene interaction (59.3% vs. 25.7%; AD 33.6%, 95% CI 28.9 to 38.4) Secondary outcomes Significant increase in the rate of symptom remission over 24 weeks (17.2% vs. 16%; OR 1.28, 95% CI 1.05 to 1.57) Significant decrease in estimated risk of moderate drug-gene interaction (30% vs. 54.6%; ARD -24.6, 95% CI -29.5 to -19.7) Significant decrease in estimated risk of substantial drug-gene interaction (10.7% vs. 19.7%; ARD -9, 95% CI -12.7 to -5.3) Conclusion In adults with major depressive disorder who were initiating or switching treatment with a single antidepressant, pharmacogenomic-guided testing was superior to usual care with respect to estimated chance of no drug-gene interaction. Reference David W Oslin, Kevin G Lynch, Mei-Chiung Shih et al. Effect of Pharmacogenomic Testing for Drug- Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder: The PRIME Care Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):151-161. Open reference URL https://web.pathway.md/studies/recbmilW8Hfto6rHS 2/2