Clinical trial NCT03270891: Pharmacogenomic Testing in Primary Care
Official title: Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antidepressants Causing Adverse Effects in Therapeutic Use
Keywords: Pharmacogenomics
Primary care physicians
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: Count of Participants Prescribed Antidepressant Medication
timeFrame: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes:
measure: Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline and 6 months
measure: Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
timeFrame: Baseline and 6 months
measure: Change in Adherence to Refills and Medication Scale (ARMS) Scores
timeFrame: Baseline and 6 months
Other outcomes:
measure: Acceptability of PGx Testing
timeFrame: Baseline and 6 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Department of Family Medicine
name: Lorriane Buis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.