Pharmacogenomic Testing in Primary Care

Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care

This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults with a new prescription for a target antidepressant will also be enrolled.

Study Overview

• Status: Completed
• Conditions: Antidepressants Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Diagnostic test: PGx test

Detailed Description

This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results in conjunction with treating patients prescribed certain antidepressants. We will also enroll patients of these DFM physicians who are adults with a new prescription for an antidepressant (within the past 4 weeks) including patients who have switched to a new antidepressant from another antidepressant or have added on a new antidepressant to current antidepressant therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they have had PGx testing in the past. Patients will be randomized to either an intervention or control group. Patients in the intervention group will have PGx test results available soon after enrollment while the control patients will have test results available 3 months after the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control patients will have an additional 9-month assessment. Data to be collected include symptoms and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status changes, demographic information, physician and emergency department visits, adverse effects, and medication alterations and adherence.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Physician participants

Inclusion criteria:

• Be a practicing physician at a University of Michigan Department of Family Medicine clinic
• Be willing to use PGx test results for their patients enrolled in the study
• Be willing to allow study staff to contact their patients
• Self-report that they are willing to prescribe antidepressants

Exclusion criteria:

-Do not meet inclusion criteria

Patient Participants

Inclusion:

• Be a patient of a participating physician
• Have a new prescription for one of the following antidepressant medications: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra), fluvoxamine (Luvox, Luvox CR), paroxetine (Paxil, Paxil CR), sertraline (Zoloft), duloxetine (Cymbalta, Irenka), venlafaxine (Effexor), venlafaxine XR (Effexor XR), nortriptyline (Aventyl, Pamelor), bupropion (Forfivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL), mirtazapine (Remeron, Remeron Soltab), or vortioxetine (Trintellix)
• Be willing to undergo PGx testing via single tube blood draw

Exclusion:

• Do not speak English
• Have previously undergone PGx testing
• Are unable to provide their own consent to participate in the study
• Have been taking the new antidepressant prescription for longer than 4 weeks (prior to screening)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delayed intervention (control arm); Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment	Diagnostic test: PGx test; A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.; Other Names: Pharmacogenomic test; Progenity Informed PGx test
Experimental: PGx Test; Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.	Diagnostic test: PGx test; A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.; Other Names: Pharmacogenomic test; Progenity Informed PGx test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants Prescribed Antidepressant Medication	Count of participants who have been prescribed antidepressant medications which are not contraindicated	Baseline, 3 months, 6 months, and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)	Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.	Baseline and 6 months
Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)	The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.	Baseline and 6 months
Change in Adherence to Refills and Medication Scale (ARMS) Scores	Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods. The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of PGx Testing	Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Lorriane Buis, PhD, University of Michigan Department of Family Medicine

Publications and helpful links

General Publications

• Manzor Mitrzyk B, Kadri R, Farris KB, Ellingrod VL, Klinkman MS, Ruffin Iv MT, Plegue MA, Buis LR. Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study. JMIR Res Protoc. 2019 Aug 19;8(8):e13848. doi: 10.2196/13848.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): September 5, 2021
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacogenomics; Primary care physicians
• Other Study ID Numbers: HUM00121185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No