Pharmacogenomic Testing in Primary Care

NCT03270891 | Completed Results FDA Device

• 1 other identifier: HUM00121185
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Antidepressants Causing Adverse Effects in Therapeutic Use

Keywords

Pharmacogenomics; Primary care physicians

Outcome Measures

Primary Outcomes (1)

• Count of Participants Prescribed Antidepressant Medication

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

  Baseline, 3 months, 6 months, and 9 months

Secondary Outcomes (3)

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

  Baseline and 6 months

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

  Baseline and 6 months

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

  Baseline and 6 months

Other Outcomes (1)

• Acceptability of PGx Testing

  Baseline and 6 months

Study Arms (2)

Delayed intervention (control arm)

ACTIVE COMPARATOR

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

Diagnostic Test: PGx test

PGx Test

EXPERIMENTAL

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

Diagnostic Test: PGx test

Interventions

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.

Also known as: Pharmacogenomic test, Progenity Informed PGx test

Delayed intervention (control arm); PGx Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient Participants
• 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
• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 31429417 BACKGROUND

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Laurie Buis
• Organization: University of Michigan

buisl@med.umich.edu

734-998-5694

Study Officials

• Lorriane Buis, PhD

  University of Michigan Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine Assistant Professor of Information, School of Information

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 1, 2017
• Study Start: December 1, 2017
• Primary Completion: September 5, 2021
• Study Completion: May 6, 2022
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)