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

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ClinicalTrials.gov Identifier: NCT03170362
Recruitment Status : Enrolling by invitation
First Posted : May 31, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Other: Pharmacogenetic Test Not Applicable

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 contraindicated medications based on established PGx criteria than the delayed results group. (Primary Hypothesis)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study intervention is the provision of pharmacogenetic test results which can then be used to choice appropriate medication.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRIME Care (PRecision Medicine In MEntal Health Care)
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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).



Primary Outcome Measures :
  1. Depression Severity [ Time Frame: 24 weeks post randomization ]
    The investigators will use the PHQ9 as a self assessed marker of depression severity.

  2. Use of recommended medications [ Time Frame: Over the 24 week period ]
    The investigators will examine the proportion of antidepressants used that conform to the recommendations from the pharmacogenetic testing. Medication dose and selection will be considered in determining if a proscription conforms to the recommendation of the testing.


Secondary Outcome Measures :
  1. Self-reported antidepressant side effects [ Time Frame: over the 24 weeks ]
    Self reported assessment of side effects related to antidepressants. Specific questions about nausea, headache, vomiting, GI distress, and sexual dysfunction. Each item rated as not present, mild, moderate, severe

  2. Self-reported antidepressant adherence [ Time Frame: over the 24 weeks ]
    This is a interview question regarding medication adherence - taken as directed, misses some doses, misses frequent doses. We will supplement with prescription data.

  3. VR -12 - Quality of life measure [ Time Frame: 24 weeks ]
    The investigators will use the VR-12 as a self reported quality of life measure.

  4. Provider attitudes [ Time Frame: baseline and 24 weeks ]
    This is a provider assessment of knowledge and attitudes regarding pharmacogenetic testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • PTSD checklist (PCL-5) score > 39
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170362


  Show 21 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David W. Oslin, MD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Additional Information:
Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03170362     History of Changes
Other Study ID Numbers: SDR 16-348
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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

Keywords provided by VA Office of Research and Development:
Treatment
Pharmacogenetics
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders