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Clinical Trials/NCT03270891
NCT03270891
Completed
Not Applicable

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

University of Michigan1 site in 1 country75 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antidepressants Causing Adverse Effects in Therapeutic Use
Sponsor
University of Michigan
Enrollment
75
Locations
1
Primary Endpoint
Count of Participants Prescribed Antidepressant Medication
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
May 6, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lorraine Buis

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

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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