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PRIME Care (PRecision Medicine In MEntal Health Care) 2.0

NCT04958824 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-07-12

No results posted yet for this study

Summary

Background: In the last several years, commercial pharmacogenetic (PGx) testing for the selection of psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. Mostly these efforts have focused on the decision of choosing a medication. Polypharmacy has become widespread and often the norm in patients with more severe of chronic illness.

Objectives: This project is designed to evaluate the utility of PGx testing in reducing polypharmacy among Veterans with mental illness.

Methods: The project is a randomized clinical trial in which 500 Veterans will be randomly assigned to have the results of the PGx battery available to clinical staff right after randomization (i.e., the intervention group) or after 3 months of treatment as usual (i.e., the delayed results group). The study will test the following primary hypotheses:

1. Veterans with psychiatric illness and currently receiving an antidepressant and at least one additional psychotropic medication whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of reduction in polypharmacy than those in the delayed results group.
2. Veterans whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of improvement in depressive symptoms (PHQ-9 score) than the delayed results group.

Conditions

  • Psychiatric or Mood Diseases or Conditions

Interventions

DIAGNOSTIC_TEST

Pharmacogenetic test

Pharmacogenetic test results for Cytochrome P450 genes are examined for markers of variant metabolism.

Sponsors & Collaborators

  • Corporal Michael J. Crescenz VA Medical Center

    lead FED

Principal Investigators

  • David Oslin, MD · Cpl Michael J Crescenz VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2023-07-30
Completion
2024-07-30

Countries

  • United States

Study Locations

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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 NCT04958824 on ClinicalTrials.gov