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Summary

for people ages 18–80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

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)

Keywords

Major Depression Treatment Pharmacogenetics Depression Depressive Disorder, Major

Eligibility

You can join if…

Open to people ages 18–80

  • 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

You CAN'T join if...

  • 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

Locations

  • San Francisco VA Medical Center, San Francisco, CA
    San Francisco, California, 94121, United States
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, California, 94304-1290, United States
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    West Los Angeles, California, 90073, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
Links
Click here for more information about this study: PRIME Care (PRecision medicine In MEntal health Care)
ID
NCT03170362
Study Type
Interventional
Last Updated
August 22, 2017