N/A
Completed N=75
Pharmacogenomic Testing in Primary Care
Antidepressants Causing Adverse Effects in Therapeutic Use
Source: ClinicalTrials.gov NCT03270891 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Count of Participants Prescribed Antidepressant Medication — 5; 8; 5; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Prescribed Antidepressant Medication |
5; 8; 5; 8; 6; 8 | — |
| SECONDARY Change in Symptom Severity - Patient Health Questionnaire (PHQ-8) |
9.0; 8.6; 7.5; 5.8 | 0.0115 sig |
| SECONDARY Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7) |
9.1; 6.9; 6.1; 5.2 | 0.0327 sig |
| SECONDARY Change in Adherence to Refills and Medication Scale (ARMS) Scores |
17.1; 17.4; 17; 16.6 | 0.947 |
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)
Data sourced from ClinicalTrials.gov (NCT03270891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.