Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study

Abstract

Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection.

Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication.

Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained.

Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020.

Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care.

Trial registration: ClinicalTrials.gov NCT03270891; https://ichgcp.net/clinical-trials-registry/NCT03270891.

International registered report identifier (irrid): RR1-10.2196/13848.

Keywords: antidepressive agents; pharmacogenomics; primary care.

Conflict of interest statement

Conflicts of Interest: LRB is obliged to disclose a conflict of interest, as her spouse is an employee and stock option holder at Progenity.

©Beatriz Manzor Mitrzyk, Reema Kadri, Karen B Farris, Vicki L Ellingrod, Michael S Klinkman, Mack T Ruffin IV, Melissa A Plegue, Lorraine R Buis. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.08.2019.

Figures

Figure 1

Patient participant flowchart. *Patient was withdrawn from the study 3 months after enrollment because it was discovered that the physician participant listed in the electronic medical record had no previous contact with the patient, and the physician who prescribed the antidepressant did not want to enroll in the study.

Figure 2

Physician participant study flow. PGx: pharmacogenomic.

Figure 3

Patient participant study flow. PGx: pharmacogenomic.