Background: Depressive disorders are a leading cause of the burden of disease worldwide, and are growing increasingly more prevalent and debilitating. Among all mental and behavioral disorders, depression is among the most disabling. Furthermore, it is estimated that 15.7 million adults in the United States alone had at least one major depressive episode in the past year, leading to serious functional difficulties. Currently, clinicians treat depression using trial-and-error combinations of medications, which often leads to bad side effects or failure to treat the disorder and subsequent frustration on behalf of the clinician, patient, and the patient’s family. This, in turn, can lead patients to disengage from their treatment or stop taking their medications altogether. A technique called pharmacogenomics (PGx) testing may reduce the problems associated with this trial-and-error medication testing, but not many studies have been performed to identify if this testing will lead to better outcomes when compared with evidence-based guideline treatment.
Objectives: The aims of this study are (1) to compare the effectiveness of combinatorial PGx-guided treatment with best practice guideline–concordant treatment to improve well-being in individuals with major depressive disorder; and (2) to determine the characteristics of individuals with depression that might help them, their parents, and their clinicians match patients to treatments.
Methods: We plan to randomize and treat 800 individuals with major depressive disorder through a network of medical centers embedded in clinical data research networks (CDRNs) throughout the country. Patient-reported outcomes will be conducted through the existing MoodNetwork, a patient-powered research network funded by PCORI to report patient-centered outcomes.
Patient and Stakeholder Engagement: We worked closely with patients, parents, and advocacy groups to plan this study as part of the PCORnet MoodNetwork patient-powered research network as well as with the network of CDRNs that were leveraged to carry out this study. They are involved in every level of decision making, from planning the study to overseeing the dissemination of study findings.
Anticipated Impact: The findings from this study will help individuals with depression, their families, and their clinicians decide if treatment should be guided by PGx testing or best-practice guidelines. It will also help determine if particular patient characteristics will help make that choice. We anticipate that our proposed study can have a major impact on the treatment decisions and health outcomes for individuals with depression. This is consistent with PCORI’s mission to “help people make informed healthcare decisions and improve outcomes from research guided by patients.”
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.