NCT03170362

PRIME Care (PRecision Medicine In MEntal Health Care)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,944 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.

Detailed description

Background: In the last several years, commercial pharmacogenetic (PGx) testing for psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. These developments have put increasing pressure on the Veterans Health Administration to implement a mental health focused PGxs program, especially for treating depression, but without sufficient scientific study to support the utility of clinical application. Objectives: The investigators propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder. Methods: The investigators plan a multi-site RCT (n=2000), patient/provider dyads will be randomly assigned to receive results of the PGx battery right after randomization (i.e. intervention group) or after 6 months of treatment as usual (i.e. delayed results group)The study will test the following hypotheses: 1. Veterans with MDD whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of remission of depression than the delayed results group. (Primary Hypothesis) 2. Provider/patient dyads in the intervention group will use fewer medications that have potential gene-drug interactions based on commercial PGx test results than dyads in the delayed results group (Primary Hypothesis).

Conditions

• Major Depression

Interventions

Type	Name	Description
OTHER	Pharmacogenetic Test	The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.

Timeline

• Start date: 2017-06-15
• Primary completion: 2021-10-30
• Completion: 2022-03-31
• First posted: 2017-05-31
• Last updated: 2024-05-28
• Results posted: 2024-05-28

Locations

24 sites across 1 country: United States