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Pharmacogenomic Testing in Primary Care

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ClinicalTrials.gov Identifier: NCT03270891
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Lorraine Buis, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Antidepressants Causing Adverse Effects in Therapeutic Use Diagnostic Test: PGx test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Active Comparator: Delayed intervention (control arm)
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
Diagnostic Test: PGx 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

Experimental: PGx Test
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
Diagnostic Test: PGx 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 Outcome Measures :
  1. Proportion of patients prescribed antidepressant medication [ Time Frame: Baseline and 6 months ]
    Proportion of patients who have been prescribed antidepressant medications which are not contraindicated


Secondary Outcome Measures :
  1. Change in symptom severity [ Time Frame: Baseline and 6 months ]
    Change in PHQ-8 and/or GAD7 scores

  2. Change in symptoms [ Time Frame: Baseline and 6 months ]
    Change in PHQ-8 and/or GAD7 scores

  3. Change in Adherence to Refills and Medication Scale (ARMS) scores [ Time Frame: Baseline and 6 months ]
    Change in medication adherence


Other Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270891


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Lorriane Buis, PhD University of Michigan Department of Family Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lorraine Buis, Assistant Professor, Family Medicine Assistant Professor of Information, School of Information, University of Michigan
ClinicalTrials.gov Identifier: NCT03270891     History of Changes
Other Study ID Numbers: HUM00121185
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorraine Buis, University of Michigan:
Pharmacogenomics
Primary care physicians