Pharmacogenomic Testing in Primary Care

University of Michigan

Status

Completed

Conditions

Antidepressants Causing Adverse Effects in Therapeutic Use

Treatments

Diagnostic Test: PGx test

Study type

Interventional

Funder types

Other

Identifiers

NCT03270891

HUM00121185

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)