Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial

• Published in: Contemporary clinical trials 2021-02, Vol.101, p.106247-106247, Article 106247
• Main Authors: Oslin, David W., Chapman, Sara, Duvall, Scott L., Gelernter, Joel, Ingram, Erin P., Kranzler, Henry R., Lehmann, Lisa Soleymani, Lynch, Julie A., Lynch, Kevin G., Pyne, Jeff M., Shih, Mei-Chiung, Stone, Annjanette, Thase, Michael E., Wray, Laura O.
• Format: Article
• Language: English
• Subjects: Antidepressive Agents; Clinical trial; Humans; Implementation; Major depressive disorder; Mental Health; Pharmacogenetic testing; Pharmacogenetics; Pharmacogenomic Testing; Precision Medicine; Veterans
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2020.106247

Genomic testing has the potential to improve patient outcomes and reduce patient care costs by personalizing medication selection. Commercial pharmacogenetic (PGx) testing for psychotropic and other medications is widely available and promoted as a means to implement “precision medicine.” Despite evidence that genetic variation affects the metabolism of psychotropic medications, the clinical utility of these test results has not been established. Moreover, implementing such testing in routine clinical care is complex, requiring informatics support and a systematic approach to patient and provider education. The PRIME Care program is designed to bridge this gap, applying both clinical trials and implementation science methods to conduct a program of research. It is centered on a large, pragmatic randomized clinical trial (RCT) in which 2000 Veterans with a major depressive disorder (MDD) and their health care providers are randomized together to receive PGx test results at the beginning of an episode of care or 6 months later. We hypothesize that providers who receive the PGx test results will prescribe an antidepressant guided by the PGx findings and Veterans whose care is guided by PGx testing will experience higher rates of remission from MDD. If the results of the trial replicate those of prior PGx studies, which provided preliminary evidence of the utility of PGx guided prescribing, it would strongly support using a precision medicine approach to treat MDD. This program of research is also evaluating dissemination influencers, other biomarkers (e.g., genetic variation associated with depression response), and the health care cost implications of PGx testing. ClinicalTrials.gov Identifier: NCT03170362. •This research program focuses on the impact of providing depressed Veterans and their treatment providers with the results of commercial pharmacogenetic (PGx) testing for psychotropic medications.•This program of research focuses on a clinical trial but also includes cost-benefit analyses and an exploration of implementation science methods and basic clinical studies.•The outcomes of greatest interest are whether and how patients and providers use commercial genetic test results given to them when initiating or switching an antidepressant to treat Major Depressive Disorder (MDD) and whether using the test results improves patient outcomes.•MDD, one of the most common conditions associated with military service and combat exposure, increases suicide risk