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OpenTrials
Completed

NCT Number: NCT03270891

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PGx test

Diagnostic 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

Primary outcomes

  1. Count of Participants Prescribed Antidepressant Medication

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Count of participants who have been prescribed antidepressant medications which are not contraindicated

Secondary outcomes

  1. Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)

    Time frame: Baseline and 6 months

    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.

  2. Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)

    Time frame: Baseline and 6 months

    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.

  3. Change in Adherence to Refills and Medication Scale (ARMS) Scores

    Time frame: Baseline and 6 months

    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.

Other outcomes

  1. Acceptability of PGx Testing

    Time frame: Baseline and 6 months

    Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2017
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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