NCT04909749

CDDOM Oneome Rightmed Depression Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care. Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population.

Detailed description

In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care. Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population. Primary Outcomes: 1. Changes in patient depressive ratings will be the primary endpoint in this study. The primary outcome will be measured using the validated Patient Health Questionnaire (PHQ-9) depression rating scale, administered verbally to participants. Depression response and remission rates (proportion of subjects achieving or not achieving), in the control and intervention arm will be directly compared at baseline, 2, 4, 8, and 12 weeks. 2. Patient progression from primary care to El Rio behavioral health (BH) specialty care will also be monitored in this study. We will directly compare the proportion of subjects in the control and intervention arm requiring BH consultation at any point in the study. Secondary Outcomes: 1. Medication changes - Number of antidepressant medication changes and/or dose adjustments per subject from baseline to study endpoint. 2. Medication congruence - Alignment of physicians to RightMed test recommendations in control and intervention arm (guided vs unguided) and time to achieve optimal medication selection (green bin).

Conditions

• Depression, Anxiety

Interventions

Type	Name	Description
GENETIC	Oneome RightMEd Pharmacogenomic testing Kit	The RightMed test is an end-to-end solution which includes sample collection, pharmacogenomic (PGx) testing services, data analysis, and clinical interpretation that helps physicians select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on Food and Drug Administration (FDA) medication labels. The OneOme RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1.) Green - use as directed; 2.) Yellow - use with caution; and 3.) Red - adjust dose or choose alternative mediation and can be used proactively or reactively

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2021-06-02
• Last updated: 2021-06-02