Pharmacogenomic Testing in Primary Care

NCT ID: NCT03270891

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2022-05-06

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.

Conditions

Antidepressants Causing Adverse Effects in Therapeutic Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delayed intervention (control arm)

Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment

Group Type: ACTIVE_COMPARATOR

PGx test

Intervention Type: 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.

PGx Test

Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.

Group Type: EXPERIMENTAL

PGx test

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Pharmacogenomic test; Progenity Informed PGx test

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Lorraine Buis

Assistant Professor, Family Medicine Assistant Professor of Information, School of Information

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorriane Buis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Department of Family Medicine

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31429417 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00121185

Identifier Type: -

Identifier Source: org_study_id