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Pharmacogenomic Testing in Primary Care

NCT03270891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-04-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Lorriane Buis, PhD · University of Michigan Department of Family Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2021-09-05
Completion
2022-05-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270891 on ClinicalTrials.gov