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PRIME Care (PRecision Medicine In MEntal Health Care)

NCT03170362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1944

Last updated 2024-05-28

Study results available
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Summary

The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.

Conditions

Interventions

OTHER

Pharmacogenetic Test

The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • David W. Oslin, MD · Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2021-10-30
Completion
2022-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03170362 on ClinicalTrials.gov