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). 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.

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)