PRIME Care (PRecision Medicine In MEntal Health Care)

VA Office of Research and Development

Status: Completed

Conditions: Major Depression

Treatments: Other: Pharmacogenetic Test

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03170362

SDR 16-348

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,944 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,944 participants in 2 patient groups

Intervention group

Experimental group

Description:

Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.

Treatment:

Other: Pharmacogenetic Test

Delay results group

No Intervention group

Description:

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).