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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170362
Recruitment Status : Enrolling by invitation
First Posted : May 31, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 26, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE June 15, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Depression Severity [ Time Frame: 24 weeks post randomization ]
    The investigators will use the PHQ9 as a self assessed marker of depression severity.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03170362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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
  • 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.
  • Provider attitudes [ Time Frame: baseline and 24 weeks ]
    This is a provider assessment of knowledge and attitudes regarding pharmacogenetic testing.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Antidepressant side effects [ Time Frame: over the 24 weeks ]
    Self reported assessment of side effects related to antidepressants.
  • Antidepressant adherence [ Time Frame: over the 24 weeks ]
    This will be a composite measure of antidepressant prescription coverage and self reported adherence to antidepressants.
  • Self reported quality of life [ Time Frame: 24 weeks ]
    The investigators will use the VR-12 as a self reported quality of life measure.
  • Provider attitudes [ Time Frame: baseline and 24 weeks ]
    This is a provider assessment of knowledge and attitudes regarding pharmacogenetic testing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRIME Care (PRecision Medicine In MEntal Health Care)
Official Title  ICMJE PRIME Care (PRecision Medicine In MEntal Health Care)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Major Depression
Intervention  ICMJE Other: Pharmacogenetic Test
The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pharmacogenetic Test
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170362
Other Study ID Numbers  ICMJE SDR 16-348
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David W. Oslin, MD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
PRS Account VA Office of Research and Development
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP