PRIME Care (PRecision Medicine In MEntal Health Care) (PRIME Care)

May 23, 2024 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: In the last several years, commercial pharmacogenetic (PGx) testing for psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. These developments have put increasing pressure on the Veterans Health Administration to implement a mental health focused PGxs program, especially for treating depression, but without sufficient scientific study to support the utility of clinical application.

Objectives: The investigators propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder.

Methods: The investigators plan a multi-site RCT (n=2000), patient/provider dyads will be randomly assigned to receive results of the PGx battery right after randomization (i.e. intervention group) or after 6 months of treatment as usual (i.e. delayed results group)The study will test the following hypotheses:

  1. Veterans with MDD whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of remission of depression than the delayed results group. (Primary Hypothesis)
  2. Provider/patient dyads in the intervention group will use fewer medications that have potential gene-drug interactions based on commercial PGx test results than dyads in the delayed results group (Primary Hypothesis).

Study Type

Interventional

Enrollment (Actual)

1944

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72114-1706
        • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center, San Francisco, CA
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Delaware
      • Wilmington, Delaware, United States, 19805
        • Wilmington VA Medical Center, Wilmington, DE
    • Florida
      • Miami, Florida, United States, 33125
        • Miami VA Healthcare System, Miami, FL
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5153
        • New Mexico VA Health Care System, Albuquerque, NM
    • New York
      • Buffalo, New York, United States, 14215
        • VA Western New York Healthcare System, Buffalo, NY
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VA Medical Center, Cincinnati, OH
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City, UT
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center, Richmond, VA
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria
  • at least one prior treatment exposure for MDD (psychotherapy or antidepressant
  • intent to start treatment of the MDD with an antidepressant, simple dose increases will not be considered inclusionary
  • willingness to provide signed, informed consent to participate in the study

Exclusion Criteria:

  • current serious co-occurring psychiatric illness, i.e.:

    • schizophrenia
    • bipolar disorder
    • psychotic major depression
    • borderline or antisocial personality disorder
    • eating disorder
  • active alcohol or other drug use disorder
  • current use of an antipsychotic medication

  • augmentation therapy, e.g.:

    • use of two or more antidepressants at the time of randomization (trazodone at a dosage < 150 mg/day will not be considered augmentation and thus allowed)
  • patients requiring urgent care or inpatient hospitalization at the time of consent
  • currently incarcerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Other: Pharmacogenetic Test
The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
No Intervention: Delay results group
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Remission
Time Frame: 24 weeks post randomization
The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.
24 weeks post randomization
Use of Fewer Medications That Have Potential Gene-drug Interactions
Time Frame: Over the first 30 days
The investigators will examine the proportion of antidepressants prescribed in the first 30 days of the trial that have the potential for gene-drug interactions. The chance for a gene-drug interaction was classified as 1. the subject did not have a prescription for an antidepressant during the initial 4 weeks of the trial (No Antidepressant), 2 the subject was prescribed an antidepressant with no known gene-drug interaction (No Gene Interaction), 3 the subject was prescribed an antidepressant with moderate gene-drug interactions (Moderate Interaction). These are also gene-drug interactions that do not have level A concordance. And 4. the subject was prescribed an antidepressant with substantial gene-drug interactions or gene-drug interactions that are considered to have a high level of evidence to support other prescribing.
Over the first 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Severity
Time Frame: 24 Weeks
The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self-assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. This measure will use the PHQ9 as a continuous measure. The reported outcome is the difference in scores from baseline to 24 weeks.
24 Weeks
Depression Response
Time Frame: 24 weeks
The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Response was measured by a 50% reduction in scores from baseline to each time point.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR 16-348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to a final data set will be by request only. The investigators will set up a formal approval process which will include a request form. The investigators will require requests to include hypotheses and specify data variables requested. Requests will be reviewed by the Executive Committee for approval. If approved, the requestor will be given a user agreement specifying how the data may be used. Once the agreement is signed and returned, the investigators will provide the requester with an anonymized data set via secure transit method. The investigators will also publish a data dictionary and a primer of our research methods.

IPD Sharing Time Frame

7/1/2022

IPD Sharing Access Criteria

published with article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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